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  • PrimeGENIX Bone Complex Reviews 2025: Ingredients, Complaints, and Real Results for Men Over 40

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    NEW YORK, September 18, 2025 (Newswire.com)
    –
    Information in this article is for educational purposes only. Speak with a licensed healthcare professional before using any supplement, especially if you take medications, have a medical condition, or plan a procedure. Always check the official website for the latest price, promo eligibility, and shipping terms, since these can change at any time. This article contains affiliate links. If you purchase through these links, a commission may be earned at no additional cost to you.

    TL;DR Summary: PrimeGENIX Bone Complex targets men over 40 who want structured support for bone density and fracture risk reduction. The formula pairs MCHA with nine added nutrients, a refund window, and direct purchase guidance.

    In This Article, You’ll Discover:

    • Why PrimeGENIX Bone Complex reviews and complaints dominate search results

    • Ingredient and feature breakdowns based on public product claims

    • The most common complaints from verified customers and expected responses

    • Pros and cons mentioned by users in reviews

    • Pricing, refund policy, and where to buy with anti-counterfeit tips

    • Whether PrimeGENIX Bone Complex looks legit or a scam

    Introduction: Honest PrimeGENIX Bone Complex Reviews and Complaints in 2025

    Search interest for men’s bone support keeps rising. Men in their 40s and 50s stay active. Many want support for strength training, weekend sports, and fall prevention. Most bone pages online speak to women. Men ask where products for them exist. PrimeGENIX positions Bone Complex for this gap.

    You want facts, not hype. You also want a clear view of the risks. This review sets expectations, highlights complaint themes, and lays out next steps. You will see what the product claims, what users tend to like, and where frustration appears. You will also find refund and pricing details near the middle of the article, eliminating the need to scroll for basic buying points.

    Bone Complex centers on microcrystalline calcium hydroxyapatite, or MCHA. The brand frames MCHA as a more absorbable calcium source. It also emphasizes complementary nutrients for bone structure and turnover. These include vitamins D3 and K, magnesium, zinc, boron, copper, manganese, phosphorus, and vitamin C. The seller highlights cGMP manufacturing in the United States and a 67-day refund window. We will examine those claims in context and show how they relate to common concerns.

    Complaints often cluster around three areas. Shipping timing and tracking. Refund steps and timelines. Effects that do not match personal expectations. This piece explains how to navigate each area with simple actions. You will also see how to avoid third-party marketplaces to cut counterfeit risk.

    You will find a direct comparison section for 2025. It uses criteria you can reuse across brands. Refund clarity, label transparency, ingredient form, dosage ranges, and cultural presence. That way, you can judge PrimeGENIX Bone Complex with the same lens you use for any alternative.

    If you want a quick look at the official sales page now, use the link below. You can return here to continue this guide.

    Visit the Official PrimeGENIX Bone Complex Website

    What Is PrimeGENIX Bone Complex and How Does It Work?

    PrimeGENIX Bone Complex is a dietary supplement for men over 40. The goal is to support bone density, reduce bone loss, and lower fracture risk. The core is MCHA. MCHA mirrors the mineral matrix in human bone. The page claims better uptake than standard calcium salts. The product then layers vitamins and minerals that support bone formation, remodeling, and collagen integrity.

    Here is the high-level mechanism. Calcium and phosphorus form hydroxyapatite crystals inside bone. Vitamin D supports calcium uptake. Vitamin K supports carboxylation of osteocalcin, which binds calcium within bone. Magnesium supports bone formation enzymes and helps balance calcium status. Trace minerals, such as zinc, copper, manganese, and boron, support collagen cross-linking, bone matrix formation, and bone turnover. Vitamin C supports collagen synthesis and offers antioxidant support. The formula design seeks synergy. Better inputs in the right ratios help bone tissue retain structure under load.

    Men face unique risks. Activity intensity, higher body mass, and impact sports increase load on the hips, spine, wrists, and ankles. A product that targets density and matrix strength aligns with those stressors. The seller also frames MCHA as a way to address concerns linked to standard calcium pills. The sales page claims low absorption for standard salts and promotes MCHA as a better option. This review keeps the language neutral and urges medical guidance for dosing and lab work. You should confirm vitamin D levels, kidney function, and medication interactions with your provider.

    Responsible use means patience. Bone remodeling runs on months, not days. You set a daily routine, track training volume, and get daylight exposure where safe. You also set realistic goals. Support products do not replace resistance training, protein intake, sleep, and safety habits. The formula can support a broader plan. Use the refund window as a guardrail while you test fit.

    Ingredient Breakdown

    This section explains each named component in plain terms. If a specific dose is not confirmed on a label screenshot, treat the following as generalized guidance. Speak with your clinician for personal dosing and lab monitoring. Do not exceed directions on the bottle.

    MCHA, microcrystalline calcium hydroxyapatite. This form includes calcium and phosphorus in a ratio found in bone. The page highlights potential benefits for absorption and tolerance. Source quality matters. The brand states bovine origin from New Zealand sources. You should confirm allergen status and dietary fit.

    Vitamin D3. Supports calcium absorption and bone mineralization. Many adults show low baseline levels. Ask your provider for a 25 OH D test before high-dose use. Excess intake can raise calcium too high. That risk calls for medical oversight, especially if you take thiazides or have kidney issues.

    Vitamin K supports the activation of osteocalcin, which helps bind calcium in bone. Vitamin K interacts with blood thinners such as warfarin. If you use anticoagulants, speak with your prescriber before use.

    Magnesium. Supports bone formation enzymes and helps balance calcium. Diets often fall short. High-dose magnesium can loosen stools. Start within the label range and take with food.

    Zinc. Supports bone growth and repair. High zinc for long periods can reduce copper status. Balanced multimineral formulas help manage that risk.

    Boron. Supports mineral metabolism and may help calcium retention. Keep intake within safe ranges. More is not always better.

    Copper. Supports collagen cross-linking. Excess intake can stress the liver. Balance with zinc matters.

    Manganese. Supports enzyme systems for bone matrix. Excess intake can have neurologic effects. Stay within label limits.

    Vitamin C supports collagen synthesis. Intake from food plus a modest supplement dose often suffices.

    Phosphorus. Present within MCHA. Supports the hydroxyapatite structure. Excess phosphorus from sodas and processed foods can harm bone health. The MCHA source targets a structural role rather than free phosphate load.

    The seller claims cGMP production in the United States. That aligns with quality system controls. Many buyers want third-party testing details and contaminant screens. Request support for a recent certificate of analysis if you have specific requirements.

    If you want to check the current panel and any updates before ordering, use the link below.

    Review the Current Ingredient Profile

    Pros and Cons of PrimeGENIX Bone Complex

    Pros

    A man-focused angle helps with adherence. Men over 40 want direct language, simple dosing, and support for active life. A single formula offers structure. The MCHA bases its approach on bone biology. Added vitamins and minerals to cover common gaps, such as D and magnesium. The cGMP note and U.S. production will appeal to quality-minded buyers. A 67-day refund window reduces risk during a first run. The seller directs buyers to order directly, which can reduce the risk of counterfeit products from third-party marketplaces.

    Cons

    Results vary with diet, training, sleep, and baseline labs. Some buyers expect rapid changes, which can create frustration. Supplements take time. Shipping and tracking issues appear in many complaint clusters across the category. Refunds also require steps, such as returns within a window and order verification. Label clarity and third-party test access may seem insufficient if a buyer anticipates full COA links in the checkout process. MCHA source raises dietary fit questions for some. The vitamin K component will not fit users on warfarin. Multi-capsule daily ranges can bother users who want a single pill.

    If you want to see current offers before you read complaints and solutions, tap the link below.

    See If PrimeGENIX Bone Complex Is Right for You

    The Biggest Complaints About PrimeGENIX Bone Complex

    Shoppers raise three themes most. Shipping, refunds, and results. Each theme has simple fixes. Start with shipping. Late deliveries frustrate buyers. Weekends and holidays extend timelines. Weather and carrier scans create gaps. Use order confirmation, tracking emails, and carrier apps. Save the order number and the email used at checkout. Use those for quick lookups with support. Photograph the box on arrival in case damage shows up later.

    Refunds come next. Buyers expect frictionless money returns. The brand lists a 67-day window. Returns still need steps. Keep the original bottles and packaging. Save receipts and tracking numbers for the return. Photograph the return box with the shipping label. Use a carrier with tracking. Watch for refund confirmation emails after delivery back to the warehouse. If nothing posts in your statement after a full billing cycle, contact support with timestamps and photos. Ask for the RMA instructions before you ship anything.

    Results drive most complaints in this category. Bone remodeling runs slowly. Most adults expect changes in weeks. DEXA scans often run six to twelve months apart. Set a baseline first. Discuss training, protein intake, vitamin D status, and sleep hours with your clinician. Log daily use for accountability. Align expectations with the biology. A supplement supports a plan. It does not replace strength training, balance work, or fall prevention habits.

    Two more issues surface at times. Capsules per day and vitamin K. The multi-capsule range can feel tedious for some users. Prepare a simple routine linked to one daily meal. Vitamin K conflicts with warfarin. Anyone on anticoagulants must seek medical advice first. The same holds for kidney disease, parathyroid disorders, and a history of high calcium. Buyers also ask for third-party testing. Ask for a recent certificate of analysis. Save it with your order records.

    If you want direct help before ordering, use the link below for current policies.

    Related: PrimeGENIX Prostate Support Reviews 2025: Dual-Action Relief

    Positive Reviews: Why Customers Like PrimeGENIX Bone Complex

    Positive feedback highlights four points. Simple daily routine, targeted design for men, broad nutrient coverage, and a clear refund policy. Adherence stays higher when a product fits a daily meal. Many buyers prefer a formula that speaks to male activity and risk profiles. MCHA serves as the anchor. Added D3, K, magnesium, zinc, boron, copper, manganese, phosphorus, and vitamin C to create a complete feel. That reduces the urge to stack random pills with unknown overlap.

    Community voices often mention joint confidence during sports, peace of mind after a scan, and fewer supplement bottles on the counter. Content creators point to label logic and cGMP production. Blog and podcast hosts favor direct purchase links to avoid marketplace issues. Reddit threads in adjacent health communities often praise step-by-step routines. They value consistency over novelty. TikTok clips skew toward “what I take” list videos. Those clips show morning or dinner supplement setups, which promote adherence.

    Reviewers who track health metrics, such as structure. They log daily use, sleep, protein intake, and training volume. They schedule a DEXA at baseline and a second scan months later. They add balance drills and grip strength tests. They monitor vitamin D levels with their provider. That mindset drives stronger reviews. The supplement supports a broader plan with measurable checkpoints.

    Customer service notes appear in positive posts when agents answer quickly and replace damaged shipments without hassle. Clear return emails and tracking updates earn praise. Direct site orders also get higher trust. Buyers dislike counterfeit risk on large marketplaces. The brand’s site provides control over batch and storage conditions.

    Ready to explore current offers and read more customer notes.

    Is PrimeGENIX Bone Complex Legit or a Scam?

    Legitimacy rests on five signals. Transparent claims, refund terms, manufacturing standards, realistic timelines, and support access. The brand frames claims around support for bone density and structure. The copy includes FDA and health disclaimers. That aligns with supplement rules. A 67 day refund window adds consumer protection. cGMP production in the United States supports quality systems. The page avoids miracle promises and urges daily use over time. That language matches realistic timelines for bone remodeling.

    Red flags to watch across any brand include hidden rebills, aggressive countdown timers, fake celebrity endorsements, and unverifiable studies. This sales page lists prices upfront and presents a stable cart. The refund policy shows clear steps. Third-party logos appear as background to a physician’s bio, with a footnote that clarifies no direct connection. That level of disclosure reduces confusion.

    Independent verification still helps. Ask for a certificate of analysis. Confirm vitamin D, K, and mineral amounts on the current label. Check the phone lines for live agent access during the listed hours. Search your bank statement descriptors after a small test order to verify the merchant record. Use a credit card for added buyer protection.

    Bottom line. The offer shows standard legitimacy signals for a direct-to-consumer supplement. The refund window length, cGMP note, and disclosures support that view. Results vary by baseline status and routine. Set expectations with your clinician and use objective checkpoints.

    Expert Insights and Industry Research

    Public data shows fracture risk rising with age in men, not only in women. Vitamin D insufficiency is common in adults. Diets often fall short on magnesium. Strength training and balance work reduce falls. Supplements play a supporting role in broader plans that include protein targets and outdoor activity. Clinical literature on MCHA discusses bone mineralization support in the context of calcium and phosphorus delivered in a matrix form. Vitamin K supports osteocalcin activation. Vitamin C supports collagen synthesis. Trace minerals support enzyme pathways involved in matrix formation and turnover.

    Affordability influences adherence. Multi-product stacks add cost and confusion. A single formula simplifies routines and reduces errors. Direct site orders reduce counterfeit risk and make returns easier to manage. Refund windows increase trial confidence. Clear support lines and posted hours help resolve shipment or label questions.

    Experts urge lab work before high-dose fat-soluble vitamins. A 25 OH D test guides vitamin D intake. Kidney function labs and medication reviews reduce adverse events. Warfarin users must get prescriber guidance before any vitamin K product. Creatine, whey protein, and resistance training pair well with bone support plans for many men, when cleared by a clinician. Sunlight exposure, calcium from food, and fall prevention practices complete the plan.

    Your next step is simple. Map your plan. Baseline DEXA if eligible. Lab work for vitamin D and kidney function. Strength and balance routine. Protein target by body weight. Daily supplement routine linked to one meal. Follow up with your provider in twelve weeks. Repeat labs and adjust.

    Review the product details while you outline that plan.

    Learn the Facts About PrimeGENIX Bone Complex

    Comparing PrimeGENIX Bone Complex vs Alternatives in 2025

    Use a clear framework. Start with refund terms. Longer windows reduce risk. Next, check the ingredient form. MCHA vs calcium carbonate or citrate. Then, check vitamin D and K forms and doses. Review magnesium form and amount. Scan for zinc, boron, copper, manganese, phosphorus, and vitamin C. Seek balanced ratios to avoid long-term imbalances, such as excess zinc without copper.

    Look at transparency and testing. Brands that provide recent COAs on request score higher. Check the cGMP notes and the manufacturing country. Review the capsule count per day and the total cost per month. Price comparisons only matter with equal forms and doses. Watch for proprietary blends that hide amounts. That approach blocks fair comparisons.

    Consider cultural presence and education. Brands that publish how-to guides on training, protein intake, and fall prevention serve user needs better. Check customer service access. Live phone lines and posted hours matter. Finally, review counterfeit risk. Direct site orders reduce exposure to gray market resellers.

    Where does PrimeGENIX fit? The offer lists MCHA plus nine nutrients, cGMP production, and a 67-day refund window. The site lists phone support with U.S. and international numbers and posted hours. Pricing sits in the mid-range for a multi-nutrient bone formula. Dosing uses a one to six capsule range with a once-daily routine linked to meals.

    Use this framework on any shortlist. Print it or save it in notes. Then match each brand line by line. Pick the product that fits your lab plan, budget, and routine.

    Check PrimeGENIX prices and bundles next. Pricing details shift over time.

    Check Current Pricing for PrimeGENIX Bone Complex

    Pricing, Refund Policy, and Where to Buy

    The site lists three bundles. One month at $59.95. Three months at $159.85. Six months at $299.70. The page lists fast, free shipping to the continental U.S. on three and six-month bundles. Pricing subject to change at any time. Always confirm the final price, shipping, taxes, and any promo at checkout before you place an order. Do not buy from third-party marketplaces. Direct orders reduce counterfeit risk and simplify refunds.

    The refund policy lists a 67-day window. Keep all bottles, order numbers, and packing slips. Contact support to request return steps. Ship with tracking and a photograph of the label. Save timestamps. Refunds post to the original payment method. Banks require time to show the credit on statements. Follow up with support if a full cycle passes without a posted refund.

    Use these steps to save time. Create a simple folder in your email for order and return messages. Store photos of the box and label. Add the support phone numbers to your contacts. Set a calendar reminder for day 50 after delivery. Review progress, labs, and adherence. Decide to keep or return before the window closes.

    Order directly using the masked link below. Recheck prices and shipping before payment.

    Pricing disclaimer: always check the official website for the latest price and shipping terms. Offers change without notice.

    Safety, Risks, and Responsible Use

    Bone health support demands care. Supplements help only if used correctly. PrimeGENIX Bone Complex contains multiple minerals and vitamins. Each interacts with diet and medication. Responsible use means checking with your healthcare provider first. Men over 40 often take prescriptions. These can include blood pressure drugs, anticoagulants, or diabetes medicines. Vitamin K can alter the effect of warfarin. High doses of vitamin D affect calcium balance. Magnesium interacts with diuretics. Copper and zinc ratios matter for long-term balance. Discuss all these factors with your provider before starting.

    Follow dosage directions on the label. The suggested use is one to six capsules per day with food. Do not exceed that range. Spread doses if you take more than two capsules. Always pair supplements with adequate hydration. Take with a meal that contains protein and healthy fat. That helps absorption of fat-soluble vitamins like D and K. Skipping meals or taking on an empty stomach raises the chance of stomach upset.

    Side effects are rare but possible. Some men report mild digestive changes, such as gas or loose stool, from magnesium or vitamin C. High calcium intake can raise kidney stone risk in sensitive men. Vitamin D excess can elevate calcium levels in the blood. Symptoms of imbalance include nausea, muscle weakness, and confusion. If those appear, stop use and see your doctor. Blood tests can confirm calcium and vitamin D status. Kidney function tests provide a safe baseline.

    Set realistic expectations. Bone density does not shift in weeks. Strength training, a balanced diet, and sleep play equal or larger roles than pills. Supplements work best as part of a complete program. Do not rely on Bone Complex alone. Implement fall prevention practices, increase protein intake, encourage outdoor activity, and conduct regular lab monitoring. Keep records of daily use. Mark your calendar for follow-up scans or lab draws. Responsible use means patience and documentation.

    If you decide to try Bone Complex, use the official order link. That ensures the refund policy applies and that the product comes from verified facilities.

    User Testimonials and Case Studies

    Customer stories give context beyond ingredients. Men over 40 fit into different groups. Some are competitive athletes. Others are casual gym goers. Many want protection during outdoor work or sports. Reviews online highlight common themes. Confidence in training, fewer worries about falls, and relief in finding a men-focused formula.

    One case study comes from an endurance athlete in his late 40s. He noted stress fracture risk during long runs. His review mentioned peace of mind after adding Bone Complex to his daily meal. He paired it with vitamin D testing and strength work. Over time, he felt more secure in the volume of training.

    Another testimonial comes from a man in his mid-50s. He had a family history of hip fractures. He wrote about scanning reviews before choosing Bone Complex. His comments praised the all-in-one blend. He valued the convenience of replacing several bottles with one. His main complaint was the multi-capsule dose, but he managed it with dinner.

    Biohackers frame Bone Complex as one part of their stack. They combine it with protein powder, creatine, and mobility work. Their feedback points to tracking tools. Apps help them log consistency. That adherence fuels better outcomes.

    Preparedness communities note practical value. They want long-term bone health for manual tasks and emergency resilience. Reviews highlight the 67-day refund window. They use it as a trial plan, deciding whether to reorder after two months.

    Mainstream consumers stress cost and refunds. They compare single bottle pricing against building a stack. Many say the combined formula saves money and shelf space. Positive notes mention responsive customer service. Negative notes focus on delayed shipping. Case studies often conclude that patience and realistic expectations shape satisfaction more than any one capsule.

    To read more verified stories and see what men in your age group report, follow the link below.

    Read Verified Experiences With PrimeGENIX Bone Complex

    Frequently Asked Questions About PrimeGENIX Bone Complex Reviews and Complaints

    What are the benefits of PrimeGENIX Bone Complex?

    It supports bone density, reduces bone loss, and enhances calcium absorption. It is tailored for men over 40.

    Can you prove that it works?

    The formula combines MCHA and nine nutrients supported by research. Individual results vary. No supplement guarantees outcomes.

    When will I see results?

    Bone changes take months. Plan for six to twelve months with follow-up scans.

    Can this help prevent fractures?

    It may support bone strength, but prevention depends on multiple factors including exercise and safety habits.

    Can it help recovery after surgery or accident?

    It may support nutrient intake, but recovery should be guided by a doctor’s plan.

    Are there side effects?

    Some users report digestive issues. High calcium or vitamin D intake carries risks. Always follow label directions.

    Why is there a 67-day money-back guarantee?

    It allows time to test the product risk-free. Return policies apply only to direct orders.

    How do I get the best deal?

    Bulk orders save the most, with free shipping in the U.S. Pricing changes over time, so confirm at checkout.

    Is it safe with other supplements?

    Discuss with your doctor to avoid overlaps in minerals and vitamins.

    Is this product vegetarian?

    No. MCHA comes from bovine bone sources.

    Can women take it?

    The formula targets men, but women can discuss with their doctor if it fits their needs.

    Where is it made?

    In the U.S. in cGMP-certified facilities.

    Does it auto-bill?

    Check the cart carefully. As of this review, no hidden rebills appear on the site.

    Is PrimeGENIX Bone Complex a scam?

    The refund policy, cGMP note, and disclosures indicate it is a legitimate product. Always order from the official site.

    Bonus Tips: How to Avoid PrimeGENIX Bone Complex Complaints

    Most complaints come from missed steps. You can prevent them with a few habits:

    Order direct from the official site.

    Third-party sellers often ship expired or counterfeit stock. Only direct orders qualify for the 67-day refund window. Save the official link in your browser bookmarks.

    Track your shipments.

    Save your order confirmation email. Click the tracking link daily until delivery. Use a carrier app if available. If the package stalls for more than three business days, call support with your order number.

    Keep all packaging.

    Refunds require returns in the original bottles. Do not throw anything out until the refund posts to your card. Photograph the box when it arrives and before you return it.

    Consult your doctor.

    Show the ingredient list to your provider before you start. This prevents interactions with prescriptions such as warfarin or diuretics. A baseline vitamin D test can guide dosing.

    Set expectations.

    Bone density does not shift in weeks. Commit to at least three months of daily use with training, diet, and sleep in place. Schedule a reminder around day 50 to review progress and decide whether to reorder.

    Avoid anonymous reviews.

    Check sources. Use reputable blogs, medical journals, or verified buyers. Anonymous comments without detail often distort expectations.

    Follow these steps and you reduce refund stress, shipping delays, and mismatched expectations.

    Secure Your Order With Official Protections

    Final Verdict: Should You Try PrimeGENIX Bone Complex in 2025?

    PrimeGENIX Bone Complex aims to fill a clear gap: men over 40 seeking bone health support. The formula uses microcrystalline calcium hydroxyapatite with nine added nutrients. It provides synergy for density, structure, and collagen. The cGMP manufacturing claim and U.S.-based support quality assurance. A 67-day refund window adds safety.

    Pros:

    • Tailored for men, with MCHA anda full nutrient profile

    • Backed by a refund guarantee and U.S. phone support

    • Simple once-daily dosing tied to a meal

    • Direct order system reduces counterfeit risk

    Cons:

    • Bone density improvements require months of consistency

    • Multi-capsule serving may frustrate some users

    • Vitamin K content is unsuitable for warfarin users

    • No instant results, leading to unmet expectations for some buyers

    Who should consider it? Active men in their 40s and 50s, men with a family history of fractures, or men seeking complete bone support in one formula. Who should avoid it? Those on blood thinners, men with a history of kidney stones without doctor clearance, or anyone unwilling to commit to daily use for months.

    Is it legit? The disclosures, refund terms, and transparent claims indicate legitimacy. It does not promise miracles. It positions itself as structured support inside a broader health plan.

    If your doctor agrees and you want an all-in-one supplement for bone support, PrimeGENIX Bone Complex is worth a trial run. Use the refund window as a risk-free safety net.

    Also Read: Comprehensive 2025 Guide to PrimeGENIX Micronized Creatine Monohydrate Reviews, Ingredients, Side Effects, Pricing, and Expert Safety Insights

    Contact Information

    • Company: PrimeGENIX

    • Parent Company: Leading Edge Health Inc. / Leading Edge Health Ltd.

    • U.S. Phone (Toll-Free): 1-866-968-6643

    • International Phone: 1-778-770-2961

    • International Alternate: +1-250-999-0414

    • Hours: Monday – Friday, 6 a.m. to 6 p.m. Pacific Time

    Disclaimers

    Publisher Responsibility Disclaimer: The publisher of this article has made every effort to ensure accuracy at the time of publication. We do not accept responsibility for errors, omissions, or outcomes resulting from the use of the information provided. Readers are encouraged to verify all details directly with the official source before making a purchase decision.

    FTC Affiliate Disclosure: This article contains affiliate links. If you purchase through these links, a commission may be earned at no additional cost to you.

    FDA Disclaimer: These statements have not been evaluated by the Food and Drug Administration. PrimeGENIX Bone Complex is not intended to diagnose, treat, cure, or prevent any disease.

    Results Disclaimer: Results vary based on diet, training, baseline bone density, and health status. No outcomes are guaranteed.

    Pricing Disclaimer: Pricing, promotions, and shipping terms change without notice. Always verify final costs on the official website before placing an order.

    Contact Information

    PrimeGENIX Customer Service
    1-866-698-6950

    Source: PrimeGENIX

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  • Does Marijuana Affect Weight Gain or Bone Density?  | NutritionFacts.org

    Does Marijuana Affect Weight Gain or Bone Density?  | NutritionFacts.org

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    Are the apparent adverse effects of heavy cannabis use on the bone just due to users being thinner? 

    It’s been recognized for decades that cigarette smoking can have “a major effect” on bone health, “increasing the lifetime risk of hip fracture by about half.” It also appears to impair bone healing, so much so that surgeons ask if they should discriminate against smokers because their bone and wound-healing complication rates are so high. What about smoking marijuana?

    As I discuss in my video Effects of Marijuana on Weight Gain and Bone Density, “There is accumulating evidence to suggest that cannabinoids [cannabis compounds] and their receptors play important roles in bone metabolism by regulating bone mass, bone loss, and bone cell function.” Okay, but are they “friend or foe?” 

    “Results from research on cannabinoids and bone mineral density in rodent models have been inconsistent. Some studies show increased bone formation, others have demonstrated accelerated bone loss, and yet others have shown no association. This variation in results may be due [in part] to differences in the mouse strain, sex, age…” If you can’t even extrapolate from one mouse to another, how can you extrapolate from mice to human beings?

    What if you just measure cannabis use and bone mineral density in people? Researchers tested thousands of adults and asked them about their cannabis use. There did not appear to be any link between the two, which is a relief. However, in this study, “heavy” cannabis use was defined as just five or more days of use in the previous 30 days. The researchers didn’t ask beyond that, so, theoretically, someone who smoked just five joints in their entire life could be categorized as a “heavy user” if they happened to use it five times in the last four weeks.

    How about cannabis use on 5,000 separate occasions over a lifetime? Now that’s a heavy user—decades of regular use. In that case, heavy use was “associated with low bone mineral density and an increased risk of fractures”—about double the fracture rate presumably due to lower bone density in the hip and spine, although heavy cannabis users were also thinner on average, and thinner people have lighter bones.

    Hip fracture risk goes down as our weight goes up. Nearly half of underweight women have osteoporosis, but less than 1 percent of obese women do, which makes total sense. Being obese forces our body to make our bones stronger to carry around all of that extra weight. That’s why weight-bearing exercise is so important to constantly put stress on our skeleton. When it comes to our bones, it’s use it or lose it. That’s why astronauts can lose a percent of their bone mass every month in “long-duration spaceflight.” Their bodies aren’t stupid. Why waste all that energy making a strong skeleton if you aren’t going to put any weight on it? 

    So, maybe the reason heavy cannabis users have frailer bones is because they tend to be about 15 pounds lighter. Wait a second. Marijuana users are slimmer? What about the munchies? “The lower BMI that was observed in heavy cannabis users at first sight seems counterintuitive,” given marijuana’s appetite stimulation, but this isn’t the first time this has been noted. 

    “Popular culture commonly depicts marijuana users as a sluggish, lethargic, and unproductive subculture of compulsive snackers,” and marijuana has indeed been found to increase food intake. A single hit can increase appetite, so you’d expect obesity rates to rise in states that legalized it. But, if anything, the rise in obesity appeared to slow after medical marijuana laws were passed, whereas it appeared to just keep rising in other states, as you can see in the graph below and at 3:45 in my video. 

    The reason pot smokers may be slimmer is because of the effect of smoked marijuana on metabolism. We’ve known for more than nearly 40 years that within 15 minutes of lighting up, our metabolic rate goes up by about 25 percent and stays there for at least an hour, as you can see below and at 4:04 in my video. So, that may be playing a role. 

    Is that why heavy cannabis use is associated with lower bone mineral density and increased risk of fractures? Because users just aren’t as overweight? No. Even when taking BMI into account, heavy cannabis use appears to be “an independent predictor” of weaker bones.

    I originally released a series of marijuana videos in a webinar and downloadable digital DVD. There are still a few videos coming out over the next year, but if you missed any of the already published ones, see the related posts below. 

    For more on bone health, check out the related posts below. 

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    Michael Greger M.D. FACLM

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  • How Safe Is Alternate-Day Intermittent Fasting?  | NutritionFacts.org

    How Safe Is Alternate-Day Intermittent Fasting?  | NutritionFacts.org

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    Eating every other day can raise your cholesterol. 
     
    Are there any downsides to fasting every other day? For example, might go all day without eating impair your ability to think clearly? Surprisingly, as I discuss in my video Is Alternate-Day Intermittent Fasting Safe?, the results appear to be “equivocal.” Some studies show no measurable effects and the ones that do fail to agree on which cognitive domains are affected. Might the cycles of fasting and feasting cause eating disorder–type behaviors, like bingeing? So far, no harmful psychological effects have been found. In fact, there may be some benefit. However, the studies that have put it to the test specifically excluded those with a documented history of eating disorders, for whom the effects may differ. 
     
    What about bone health? No change in bone mineral density was noted after six months of alternate-day fasting despite about 16 pounds of weight loss, which would typically result in a dip in bone mass. However, the researchers did not note any skeletal changes in the control group either, and they lost a similar amount of weight using continuous caloric restriction. They suggested this is because both groups tended to be “more physically active than the average obese American,” getting about 1,000 to 2,000 more steps a day. 
     
    Proponents of intermittent fasting suggest it can better protect lean body mass, but most of the intermittent trials have employed less accurate methods of body composition analysis, whereas the majority of continuous caloric restriction trials used “vastly more accurate techniques.” So, to date, it is not clear if there’s a difference in lean mass preservation. 
     
    Improvements in blood pressure and triglycerides have been noted on intermittent fasting regimens, though this is presumed to be due to the reduction in body fat since the effect appears to be “dependent on the amount of weight lost.” Alternate-day fasting can improve artery function, too, as you can see in the graph below and at 1:55 in my video, though it does depend on what you’re eating on the non-fasting day. For study participants randomized to an alternate-day diet high in saturated fat, their artery function worsened despite a ten-pound weight loss, whereas it improved, as expected, in the lower-fat group. The decline in artery function was presumed to be because of the pro-inflammatory nature of saturated fat. 

    A concern has been raised about the effects of alternate-day fasting on cholesterol. After 24 hours without food, LDL cholesterol may temporarily bump up, but this is presumably because so much fat is being released into the system by the fast. As you can see in the graph below and at 2:33 in my video, an immediate negative effect on carbohydrate tolerance may stem from the same phenomenon—the repeated elevations of free fat floating around in the bloodstream. After a few weeks, though, LDL levels start to drop as the weight comes off. However, results from the largest and longest trial of alternate-day fasting have given me pause. 


    A hundred obese men and women were randomized into one of three groups: alternate-day modified fasting (25 percent of their baseline calories on fasting days and 125 percent calories on eating days), continuous, daily caloric restriction (75 percent of baseline), or a control group instructed to maintain their regular diet. So, for those going into the trial eating 2,000 calories a day, they would continue to eat 2,000 calories a day in the control group. The calorie-restriction group would get 1,500 calories every day, and the intermittent-restriction group would alternate between 500 calories a day and 2,500 calories the next. 
     
    As you can see in the graph below and at 3:32 in my video, with the same overall, average, prescribed calorie cutting in the two weight-loss groups, they both lost about the same amount of weight, but, surprisingly, the cholesterol effects were different. In the continuous calorie-restriction group, the LDL levels dropped as expected compared to the control group as the pounds came off. 

    But, in the alternate-day modified fasting group, they didn’t, as you can see below, and at 3:55 in my video. At the end of the year, the LDL cholesterol in the intermittent fasting group ended up being 10 percent higher than in the constant calorie-restriction group—despite the same loss of body fat. Given that LDL cholesterol is a prime causal risk factor for heart disease, our number one killer—or is even the prime risk factor—this strikes a significant blow against alternate-day fasting. If you want to try it anyway, I would advise you to have your cholesterol monitored to make sure it comes down with your weight. 


    If you’re diabetic, you must talk with your physician about medication adjustment for any changes in diet, including fasting of any duration. Even with proactive medication reduction, advice to immediately break the fast should sugars drop too low, and weekly medical supervision, people with type 2 diabetes who fasted for even just two days a week were twice as likely to suffer from hypoglycemic episodes compared to an unfasted control group. We still don’t know the best way to tweak blood sugar medications to prevent blood sugar from dropping too low on fasting days. 
     
    Even fasting for just one day can significantly slow the clearance of some drugs (like the blood-thinning drug Coumadin) or increase the clearance of others (like caffeine). Fasting for 36 hours can cut your caffeine buzz by 20 percent. So, consultation with your medical professional before fasting is an especially good idea for anyone on any kind of medication. 

    If you missed it, check out Alternate-Day Intermittent Fasting Put to the Test. 
     
    So, with ambiguous cognitive, lean mass, and bone effects, plus these cholesterol findings, I wouldn’t suggest alternate-day fasting for weight loss, but dropping pounds isn’t the only thing this way of eating is purported to do. Check out Does Intermittent Fasting Increase Human Life Expectancy?. 
     
    For other types of intermittent fasting, total fasting, and more on fasting, check out the related videos below. 



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  • Any Pitfalls with Restricting Calories?  | NutritionFacts.org

    Any Pitfalls with Restricting Calories?  | NutritionFacts.org

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    How may we preserve bone and mass on a low-calorie diet? 
     
    One of the most consistent benefits of calorie restriction is that blood pressure improves in as little as one or two weeks. Blood pressure may even be normalized in a matter of weeks and blood pressure pills discontinued. Unfortunately, this can work a little too well and cause orthostatic intolerance, which can manifest as lightheadedness or dizziness upon standing and, in severe cases, may cause fainting, though staying hydrated can help. 
     
    What about loss of muscle mass? In the CALERIE trial, which I profile in my video Potential Pitfalls of Calorie Restriction, 70 percent of the body weight the subjects lost was fat and 30 percent was lean body mass. So, they ended up with an improved body composition of about 72 percent lean mass compared to 66 percent in the control group, as you can see at 0:51 in my video. And, even though leg muscle mass and strength declined in absolute terms, relative to their new body size, they generally got stronger. 

    Is there any way to preserve even more lean mass, particularly among older individuals who naturally tend to lose muscle mass with age? Increased protein intakes are commonly suggested, but most studies fail to find a beneficial effect on preserving muscle strength or function whether you’re young or old, active or sedentary. For example, during a 25 percent calorie restriction, researchers randomized overweight older men and women to either a normal-protein diet with 4 grams for every ten pounds of body weight or a high-protein diet with about 8 grams per ten pounds. That doubling of protein intake had no discernible effect on lean body mass, muscle strength, or physical performance. As you can see below and at 1:48 in my video, most such studies found the same lack of benefit, but when they’re all put together, one can tease out a small advantage of about one or two pounds of lean mass over an average of six months. 

    Unfortunately, high protein intake during weight loss has also been found to have “profound” negative metabolic effects, including undermining the benefits of weight loss on insulin sensitivity. As you can see in the graph below and at 2:14 in my video, if you lose 20 pounds, you can dramatically improve your body’s ability to handle blood sugars, compared to subjects in a control group who maintained their weight. But, if you lose the exact same amount of weight on a high-protein diet, getting about an extra 30 grams a day, it’s like you never lost any weight at all. 


    Though you can always bulk back up after weight loss, the best way to preserve muscle mass during weight loss is to exercise. The CALERIE study had no structured exercise component, and, similar to bariatric surgery, about 30 percent of the weight loss was lean mass. In contrast, that proportion was only about 16 percent of The Biggest Loser contestants, chalked up to their “vigorous exercise program.” Resistance training even just three times a week can prevent more than 90 percent of lean body mass loss during calorie restriction. 
     
    The same may be true of bone loss. Lose weight through calorie restriction alone, and you experience a decline in bone mineral density in fracture risk sites, such as the hip and spine. In the same study, though, those randomized to lose weight with exercise did not suffer any bone loss. The researchers concluded: “Our results suggest that regular EX [exercise] should be included as part of a comprehensive weight loss program to offset the adverse effects of CR [caloric restriction] on bone.” 
     
    It’s hard to argue with calls for increased physical activity, but even without an exercise regimen, the “very small” drop in bone mineral density in the CALERIE trial might only increase a ten-year risk of osteoporotic fracture by about 0.2 percent. The benefits of calorie restriction revealed by the study included improvements in blood pressure and cholesterol, as you can see in the graph below and at 3:54 in my video, as well as improved mood, libido, and sleep. These would seem to far outweigh any potential risks. The fact that a reduction in calories seemed to have such wide-ranging benefits on quality of life led commentators in the AMA’s internal medicine journal to write: “The findings of this well-designed study suggest that intake of excess calories is not only a burden to our physical homeostasis [or equilibrium], but also on our psychological well-being.” 
     


    Check out my other videos on calorie restriction, fasting, intermittent fasting, and time-restricted eating in the related videos below. 

     

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  • Muscle Shrinkage and Bone Loss on Keto Diets?  | NutritionFacts.org

    Muscle Shrinkage and Bone Loss on Keto Diets?  | NutritionFacts.org

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    Ketogenic diets have been found to undermine exercise efforts and lead to muscle shrinkage and bone loss. 
     
    An official International Society of Sports Nutrition position paper covering keto diets notes the “ergolytic effect” of keto diets on both high- and low-intensity workouts. Ergolytic is the opposite of ergogenic. Ergogenic means performance-boosting, whereas ergolytic means performance-impairing. 
     
    For nonathletes, ketosis may also undermine exercise efforts. Ketosis was correlated with increased feelings of “perceived exercise effort” and “also significantly correlated to feelings of ‘fatigue’ and to ‘total mood disturbance,’” during physical activity. “Together, these data suggest that the ability and desire to maintain sustained exercise might be adversely impacted in individuals adhering to ketogenic diets for weight loss.” 
     
    You may recall that I’ve previously discussed that shrinkage of measured muscle mass among CrossFit trainees has been reported. So, a ketogenic diet may not just blunt the performance of endurance athletes, but their strength training as well. As I discuss in my video Keto Diets: Muscle Growth and Bone Density, study participants performed eight weeks of the battery of standard upper and lower body training protocols, like bench presses, pull-ups, squats, and deadlifts, and there was no surprise. You boost muscle mass—unless you’re on a keto diet, in which case there was no significant change in muscle mass after all that effort. Those randomized to a non-ketogenic diet added about three pounds of muscle mass, whereas the same amount of weight lifting on the keto diet tended to subtract muscle mass by about 3.5 ounces on average. How else could you do eight weeks of weight training and not gain a single ounce of muscle on a ketogenic diet? Even keto diet advocates call bodybuilding on a ketogenic diet an “oxymoron.” 
     
    What about bone loss? Sadly, bone fractures are one of the side effects that disproportionately plague children placed on ketogenic diets, along with slowed growth and kidney stones. Ketogenic diets may cause a steady rate of bone loss as measured in the spine, presumed to be because ketones are acidic, so keto diets can put people in what’s called a “chronic acidotic state.” 
     
    Some of the case reports of children on keto diets are truly heart-wrenching. One nine-year-old girl seemed to get it all, including osteoporosis, bone fractures, and kidney stones, then she got pancreatitis and died. Pancreatitis can be triggered by having too much fat in your blood. As you can see in the graph below and at 2:48 in my video, a single high-fat meal can cause a quintupling of the spike in triglycerides in your bloodstream within hours of consumption, which can put you at risk for inflammation of the pancreas.  

    The young girl had a rare genetic disorder called glucose transporter deficiency syndrome. She was born with a defect in ferrying blood sugar into her brain. That can result in daily seizures starting in infancy, but a ketogenic diet can be used as a way to sneak fuel into the brain, which makes a keto diet a godsend for the 1 in 90,000 families stricken with this disorder.

    As with anything in medicine, it’s all about risks versus benefits. As many as 30 percent of patients with epilepsy don’t respond to anti-seizure drugs. Unfortunately, the alternatives aren’t pretty and can include brain surgery that implants deep electrodes through the skull or even removes a lobe of your brain. This can obviously lead to serious side effects, but so can having seizures every day. If a ketogenic diet can help with seizures, the pros can far outweigh the cons. For those just choosing a diet to lose weight, though, the cost-benefit analysis would really seem to go the other way. Thankfully, you don’t need to mortgage your long-term health for short-term weight loss. We can get the best of both worlds by choosing a healthy diet, as I discussed in my video Flashback Friday: The Weight Loss Program That Got Better with Time.
     
    Remember the study that showed the weight loss was nearly identical in those who had been told to eat the low-carb Atkins diet for a year and those told to eat the low-fat Ornish diet, as seen below and at 4:18 in my video? The authors concluded, “This supports the practice of recommending any diet that a patient will adhere to in order to lose weight.” That seems like terrible advice. 

    There are regimens out there like “The Last Chance Diet which consisted of a low-calorie liquid formula made from leftover byproducts from a slaughterhouse [that] was linked to approximately 60 deaths from cardiovascular-related events.” An ensuing failed lawsuit from one widower laid the precedent for the First Amendment protection for those who produce deadly diet books. 

    It’s possible to construct a healthy low-carb diet or an unhealthy low-fat one—a diet of cotton candy would be zero fat—but the health effects of a typical low-carb ketogenic diet like Atkins are vastly different from a low-fat plant-based diet like Ornish’s. As you can see in the graph below and at 5:26 in my video, they would have diametrically opposed effects on cardiovascular risk factors in theory, based on the fiber, saturated fat, and cholesterol contents of their representative meal plans. 

    And when actually put to the test, low-carb diets were found to impair artery function. Over time, blood flow to the heart muscle itself is improved on an Ornish-style diet and diminished on a low-carb one, as shown below and at 5:44 in my video. Heart disease tends to progress on typical weight-loss diets and actively worsens on low-carb diets, but it may be reversed by an Ornish-style diet. Given that heart disease is the number one killer of men and women, “recommending any diet that a patient will adhere to in order to lose weight” seems irresponsible. Why not tell people to smoke? Cigarettes can cause weight loss, too, as can tuberculosis and a meth habit. The goal of weight loss is not to lighten the load for your pallbearers. 

     
    For more on keto diets, see my videos on the topic. Interested in enhancing athletic performance? Check out the related videos below. 

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  • Landscape for AML Patients Evolving Rapidly as Research Discoveries Advance New Treatments

    Landscape for AML Patients Evolving Rapidly as Research Discoveries Advance New Treatments

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    Newswise — MIAMI, FLORIDA (EMBARGOED UNTIL DEC. 10, 2023, AT 7:30 P.M. ET) – The treatment landscape for acute myeloid leukemia (AML) is evolving rapidly, as research discoveries at Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine and other academic cancer centers advance new, more effective therapies for this aggressive blood cancer. 

    “We’ve seen more progress during the past 10 years than the previous four decades combined,” said Justin M. Watts, M.D., Sylvester hematologist, associate professor of medicine, and Pap Corps Early Career Endowed Professor in Leukemia, “especially when it comes to treating older AML patients.”

    Watts, who serves as chief of the leukemia section at Sylvester, will highlight new drugs, such as Venetoclax plus Azacitidine, and new targeted therapies resulting from research advances when he leads an educational session at ASH 2023, the annual meeting of the American Society of Hematology in San Diego, Dec. 9-12.

    The session is designed to update community-based physicians who treat AML patients on current standards of care for using these new drugs sequentially or in triplet combinations with targeted inhibitors.  

    Background

    Acute myeloid leukemia is a cancer characterized by the rapid growth of abnormal cells that build up in the bone marrow and blood and interfere with normal blood-cell production. It’s one of the most common leukemia types in adults, although it’s fairly rare, accounting for about 1% of all cancers.

    It tends to afflict older adults, with 68 being the median age when first diagnosed, according to the American Cancer Society. Men are slightly more at risk than women.

    Typically, AML patients have been treated with intensive chemotherapy and a bone-marrow or stem-cell transplant. Those therapies are generally more effective in people under age 60. “We can cure about 60% of younger patients now, which is significantly better than just two decades ago,” said Watts. “But older patients, depending on their fitness level, don’t usually tolerate these treatments and historically less than 10 percent were cured, but this is now pushing 30% with the advent of venetoclax plus azacitidine and targeted inhibitors.”

    Until recently, next steps for these patients were limited to supportive care and blood transfusions, he added.

    Targeted Therapies for Mutations

    However, the outlook has improved, especially for older patients, with the emergence of new drugs and targeted inhibitors for the mutations driving AML, Watts says.

    “AML is almost always driven by mutations acquired over time,” he explained. “That’s why the risk of AML increases as we age.”

    Although there are hundreds of mutations that can cause this blood cancer, and most patients have more than one, there are five more common ones that are targetable: IDH1, IDH2, FLT3, NPM1 and MLL, Watts said. All of these now have approved therapies – or ones in development – thanks to ongoing research at Sylvester and other cancer centers.

    The results are encouraging. “We’re seeing very promising results in our studies and trials, combining Venetoclax, Azacitidine and targeted therapies, often as frontline therapy for AML,” he noted.

    Watts said the combination of Venetoclax and Azacitidine is producing good outcomes in about 52% of older patients, and the median survival is more than 2 years in these patients, with some patients living much longer.  

    Additionally, targeted therapies are proving effective, even in relapsed patients, and these treatments are also better tolerated than chemotherapy.

    Now, researchers like Watts and his colleagues must determine the best way to combine venetoclax and targeted therapies to produce the best outcomes. “That includes designing clinical trials to help us identify the optimal combinations for the right patients with specific mutations,” he explained, “and determining when we stop therapy for patients in a long remission.”

    On the Horizon

    Watts said that up to 50% of AML patients have a mutation for which there is no current targeted therapy. “We have to expand our targeted therapies to treat AML patients with harder to target mutations,” he explained, citing TP53 and RAS mutations as two common pathways for treatment resistance. “We currently have few approved therapies that are effective for these patients, especially if they are older.”

    Watts believes the future direction for AML treatment will involve targeted therapy combined with the “best backbone we have, possibly chemotherapy for younger patients or the drugs like venetoclax and azacitidine generating good results for older adults.”

    One of the biggest things that may come into play is immunotherapy, he said. “I can see us getting the immune system more involved in treating these blood cancers, as it has done with solid tumors and lymphoma.”

    Disclosures

    Dr. Watts serves on the consulting/advisory boards of Rigel, Servier, Celgene/BMS, Daiichi Sankyo, Aptose and Ativarre. He receives research funding from Takeda, Immune Systems Key Ltd, and Rigel.

    # # # 

    ASH Presentation Title:

    “The Future Paradigm of HMA + VEN or Targeted Inhibitor Approaches: Sequencing or Triplet Combinations in AML Therapy”

    Presentation Date/Time:

    Sunday, Dec. 10, 2023, 7:30 to 8:45 pm ET (4:30 to 5:45 pm PT)

    # # #

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  • ASH: Novel combination therapy significantly reduces spleen volume in patients with myelofibrosis

    ASH: Novel combination therapy significantly reduces spleen volume in patients with myelofibrosis

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    Newswise — SAN DIEGO ― Combining the JAK inhibitor ruxolitinib with the BCL-xL inhibitor navitoclax was twice as effective in reducing enlarged spleens – a major indicator of clinical improvement – compared with standard-of-care ruxolitinib monotherapy for adult patients with intermediate or high-risk myelofibrosis, a rare bone marrow cancer, according to results of the Phase III TRANSFORM-1 trial reported by researchers from The University of Texas MD Anderson Cancer Center.

    Data from the global, randomized, placebo-controlled clinical trial were presented today at the 2023 American Society of Hematology (ASH) Annual Meeting by Naveen Pemmaraju, M.D.,  professor of Leukemia. At the time of data cut-off, 63.2% of patients who received ruxolitinib and navitoclax achieved a spleen volume reduction of at least 35% within 24 weeks, compared to 31.5% of patients receiving ruxolitinib plus placebo, meeting the study’s primary endpoint.

    “By adding a second drug to an approved therapy, we were able to improve spleen volume reduction compared to the current standard of care. This is an important measurement of the clinical benefits of this novel drug combination because treatments can be less effective when the spleen remains enlarged,” Pemmaraju said. “If we can treat myelofibrosis earlier on in the disease course, we may have an opportunity to impact overall disease modificationimprove patient outcomes and reduce symptom burden.”

    Currently, there are few Food and Drug Administration-approved drugs for the treatment of myelofibrosis. Available options provide patients with spleen and symptom improvement, but a substantial unmet need remains for therapies that provide durable spleen size reduction and other longer-term clinical. Allogenic stem cell transplants are an effective treatment option, but not all patients qualify.

    This international trial enrolled 252 patients with intermediate or high-risk myelofibrosis and measurable spleen enlargement who had not received prior JAK inhibitor treatment. The trial randomized 125 patients to receive the navitoclax and ruxolitinib combination and 127 patients to receive ruxolitinib plus placebo. Most patients were male (57%) and the median age was 69.

    The trial met its primary endpoint of spleen volume reduction at 24 weeks. Spleen volume reduction at any time was achieved by 77% of patients on the combination arm and 42% of patients on the control arm. The median time to first spleen volume reduction response was 12.3 weeks with the combination and 12.4 weeks with monotherapy. At 24 weeks, there were no significant differences between the groups in a myeloproliferative neoplasm symptom assessment, a secondary endpoint of the study.

    Patients treated with the combination therapy, patients experienced side effects that were manageable and consistent with previous trials. The most common treatment-related side effects were thrombocytopenia, anemia, diarrhea and neutropenia. Serious adverse events were experienced by 26% of patients on the combination arm and 32% on the control arm.

    “This study marks a notable achievement in the field of myelofibrosis, as one of the first reported global Phase III frontline randomized combination clinical trials in our field,” Pemmaraju said. “This dataset now opens the door for additional research and investigation into combination therapies to treat myelofibrosis and, importantly, highlights a potential new era of investigating disease modification for patients. Additional data from the TRANSFORM-1 study is being evaluated.”

    The trial was funded by AbbVie. Pemmaraju receives research support from AbbVie. A full list of co-authors and their disclosures may be found here.

    Read this press release in the MD Anderson Newsroom.

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  • ASH: Novel menin inhibitors show promise for patients with advanced acute myeloid leukemias

    ASH: Novel menin inhibitors show promise for patients with advanced acute myeloid leukemias

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    Newswise — Two clinical trials led by researchers from The University of Texas MD Anderson Cancer Center demonstrated early positive results from novel therapies targeting menin for the treatment of relapsed or refractory acute leukemias with specific genetic alterations. Results from the studies were shared today in oral presentations at the 2023 American Society of Hematology (ASH) Annual Meeting. More information on all ASH Annual Meeting content from MD Anderson can be found at MDAnderson.org/ASH.

    Menin inhibitor monotherapy reduces disease burden in majority of relapsed or refractory acute leukemia patients (Abstract 57) According to data from a Phase I trial led by Elias Jabbour, M.D., professor of Leukemia, the menin inhibitor JNJ-75276617 showed early clinical activity in patients with relapsed or refractory acute leukemias and genetic alterations in KMT2A or NPM1, which are associated with poor clinical outcomes.

    Among 66 patients able to be evaluated after one month of treatment, JNJ-75276617 monotherapy reduced bone marrow disease burden in 71%, and 33 of those patients had a decrease in bone marrow blasts of more than 50%. Median time to first response was less than two months. Similar response rates were observed across patient groups with both genetic alterations.  

    “Patients with relapsed or refractory leukemias and KMT2A or NPM1 alterations often do poorly on currently available therapies, so there is a need to advance more effective options,” Jabbour said. “We are encouraged by the antileukemic activity of this monotherapy, which mimics what we saw in the preclinical setting.”

    In the multi-center clinical trial, researchers took a stepwise approach in evaluating the safety and efficacy of JNJ-75276617, a potent and selective inhibitor of the interaction between the scaffolding protein menin and the methyltransferase KMT2A. Eighty-six patients who had acute leukemias with NPM1 & KTM2A genetic alterations were included in the trial.

    Patients received the therapy orally on a 28-day cycle. Fifty-six percent of evaluable patients had AML with KMT2A alterations and 43% of evaluable patients had NPM1 alterations. The median age of trial participants was 63 years, while the median number of prior therapies was two.

    Differentiation syndrome was the most common side effect in patients, but was overcome with step-up dosing. The trial is ongoing to determine the recommended Phase II dose.

    The trial is sponsored by Janssen Pharmaceuticals. A complete list of collaborating authors and their disclosures can be found with the abstract.

    Oral therapy combination shows promising results for advanced acute leukemias (Abstract 58) The Phase I/II SAVE trial, led by Ghayas Issa, M.D., assistant professor of Leukemia, combined the menin inhibitor revumenib with venetoclax and hypomethylating agent ASTX727, yielding encouraging responses in adult and pediatric patients with relapsed or refractory advanced acute myeloid leukemia (AML) with KMT2A or NUP98 rearrangements or NPM1 mutations.

    The overall response rate among nine evaluable patients was 100%. Three patients achieved complete remission, one patient achieved complete remission with partial hematologic recovery, and three patients had complete remission with incomplete platelet count recovery. In addition, one patient had a partial response and one had a morphologic leukemia-free state. Measurable residual disease was undetectable in six of the patients. 

    “These advanced and acute leukemias often are very difficult to treat and currently have no approved targeted therapies. We believe these early results suggest this treatment will be highly effective in advanced leukemias,” Issa said. “This is our first look at an entirely oral combination therapy using menin inhibitors, and the results are very encouraging. If sustained in further trials, this could lead to a change in the standard of care for this patient population, with great potential to improve their quality of life.”

    Revumenib is a potent, oral, selective inhibitor of the menin-KMT2A interaction. To date, nine patients aged 12 years and older have been enrolled in the trial. Of those, five patients had KMT2A rearrangements, three had NUP98 rearrangements and one had mutant NPM1. On average, patients had received three prior lines of therapy.

    Side effects were manageable and consistent with previous studies. The trial is ongoing, with plans to establish the recommended Phase II dose and optimize delivery of the combination before enrolling patients in the Phase II cohort.

    This investigator-initiated study was supported by Syndax and Astex. A complete list of collaborating authors and their disclosures can be found with the abstract.

    Read this press release in the MD Anderson Newsroom.

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  • December 2023 Issue of Neurosurgical Focus: “Enhanced Recovery After Cranial Surgery”

    December 2023 Issue of Neurosurgical Focus: “Enhanced Recovery After Cranial Surgery”

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    Newswise — Rolling Meadows, IL (December 1, 2023). The October issue of Neurosurgical Focus (Vol. 55, No. 6 [https://thejns.org/focus/view/journals/neurosurg-focus/55/6/neurosurg-focus.55.issue-6.xml]) presents twelve articles and one editorial on enhanced recovery after cranial surgery. 

    Topic Editors: Walavan Sivakumar, Neil Martin, Sarah T. Menacho, Randy S. D’Amico, and Luca Regli 

    Following on earlier attention to enhanced recovery in spine surgery, the December issue of Neurosurgical Focus focuses on enhance recovery after cranial surgery. The issue’s editors present “a contemporary and global selection of evidence-based studies encompassing the range of cranial surgery” with the “hope that this issue will serve as a valuable reference for the readership in their own protocol development efforts.” 

    Contents of the December issue: 

    • “Introduction. Developing the foundation for enhanced recovery after cranial surgery” by Walavan Sivakumar et al.
    • “Theory-based implementation of an enhanced recovery protocol for cranial surgery” by Aimun A. B. Jamjoom et al.
    • “Editorial. Overcoming implementation barriers in enhanced recovery using theory-based approaches” by Walavan Sivakumar
    • “Development and implementation of an Enhanced Recovery After Cranial Surgery pathway following supratentorial tumor resection at a tertiary care center” by Hammad A. Khan et al.
    • “Enhanced recovery after brain tumor surgery: pilot protocol implementation in a large healthcare system” by Walavan Sivakumar et al.
    • “Enhanced recovery and same-day discharge after brain tumor surgery under general anesthesia: initial experience with Hospital-at-Home–based postoperative follow-up” by Cristina A. Pelaez-Sanchez et al.
    • “Effect of the enhanced recovery protocol in patients with brain tumors undergoing elective craniotomies: a systematic review and meta-analysis” by Suchada Supbumrung et al.
    • “Same-day discharge after craniotomy for brain tumor resection: enhancing patient selection through a prognostic scoring system” by Adam S. Levy et al.
    • “The Enhanced Recovery After Surgery protocol for the perioperative management of pituitary neuroendocrine tumors/pituitary adenomas” by Giulia Cossu et al.
    • “An institutional experience in applying quality improvement measures to pituitary surgery: clinical and resource implications” by Panayiotis E. Pelargos et al.
    • “Early versus delayed mobilization after aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis of efficacy and safety” by Alberto Morello et al.
    • “Applications of enhanced recovery after surgery protocolsfor unruptured anterior circulation aneurysms in tertiary-level healthcare institutions: a national study” by Fatih Yakar et al.
    • “Effects of a sphenopalatine ganglion block on postcraniotomy pain management: a randomized, double-blind, clinical trial” by Giorgio Mantovani et al.
    • “The Enhanced Recovery After Surgery protocol for the surgical management of craniosynostosis: Lausanne experience” by Amani Belouaer et al.

     Please join us in reading this month’s issue of Neurosurgical Focus.

     ***

     Embargoed Article Access and Author/Expert Interviews: Contact JNSPG Director of Publications Gillian Shasby at [email protected] for advance access and to arrange interviews with the authors and external experts who can provide context for this research.

    ###

     The global leader for cutting-edge neurosurgery research since 1944, the Journal of Neurosurgery (www.thejns.org) is the official journal of the American Association of Neurological Surgeons (AANS) representing over 12,000 members worldwide (www.AANS.org).

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  • Recent study unveils genetics behind human head shape.

    Recent study unveils genetics behind human head shape.

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    Newswise — Researchers at the University of Pittsburgh and KU Leuven have discovered a suite of genes that influence head shape in humans. These findings, published this week in Nature Communications, help explain the diversity of human head shapes and may also offer important clues about the genetic basis of conditions that affect the skull, such as craniosynostosis.

    By analyzing measurements of the cranial vault — the part of the skull that forms the rounded top of the head and protects the brain — the team identified 30 regions of the genome associated with different aspects of head shape, 29 of which have not been reported previously.

    “Anthropologists have speculated and debated the genetics of cranial vault shape since the early 20th century,” said co-senior author Seth Weinberg, Ph.D., professor of oral and craniofacial sciences in the Pitt School of Dental Medicine and co-director of the Center for Craniofacial and Dental Genetics. “We knew from certain rare human conditions and animal experiments that genes play an important role in vault size and shape, but very little was known about the genetic basis for typical features we see in the general population, such as what makes someone’s head long and narrow versus short and wide. This study reveals some of the key genes driving variation in this part of the human body.”

    According to the researchers, one application of better understanding the factors that drive natural variation in human head shape is informing paleoanthropology studies, potentially shedding light on the early development of modern humans.

    Weinberg and colleagues used magnetic resonance (MR) scans from more than 6,000 adolescents to extract 3D surfaces corresponding to the cranial vault. After dividing the 3D vault surfaces into incrementally smaller anatomical subparts and quantifying the shape of these subparts, they tested more than 10 million genetic variants for evidence of statistical association with measures of vault shape.

    “Previous genetic studies of the cranial vault involved a small number of relatively simple measures,” added Weinberg.  “While such measures are often easy to obtain, they may fail to capture features that are biologically relevant. Our analysis used an innovative approach capable of describing 3D vault shape in much more comprehensive and nuanced ways. This approach increased our ability to find genetic associations.”

    An important discovery was that many of the strong associations are near genes that play key roles in the early formation of the head and face and regulation of bone development. For example, variants in and near the gene RUNX2, a major player in coordinating development of the skull, were associated with multiple aspects of vault shape.

    While some genes, including RUNX2, had global effects involving the entire vault, others showed more localized effects that only impacted a specific portion of the vault, such as the central forehead.

    When the researchers compared the 30 genomic regions associated with head shape across participants with European, African and Indigenous American ancestry, they found that the majority of genetic associations were shared across these different ancestral groups.

    Although the study focused on healthy participants, the findings may reveal important clues about the biological basis of diseases involving the cranial vault, according to Weinberg.

    One of these conditions is craniosynostosis, which occurs when the bones of the skull fuse too early while the brain is still growing rapidly. Without neurosurgery, craniosynostosis can cause permanent disfigurement, brain damage, blindness and even death. The team showed that variants near three genes associated with vault shape, BMP2, BBS9 and ZIC2, were also associated with craniosynostosis, suggesting that these genes could play a role in the development of the disease.

    “This kind of study is possible due to the availability of publicly funded resources,” said Weinberg. “The original study that generated these MR scans is focused on understanding brain development and behavior. By creatively leveraging these resources, we have managed to advance discovery beyond that original scope.”

    Other authors on the study were Seppe Goovaerts, Hanne Hoskens, Ph.D., Meng Yuan, Dirk Vandermeulen, Ph.D., all of KU Leuven; Ryan J. Eller, Ph.D., Noah Herrick, Ph.D., and Susan Walsh, Ph.D., all of Indiana University–Purdue University Indianapolis; Anthony M. Musolf, Ph.D., and Cristina M. Justice, Ph.D., both of the National Human Genome Research Institute; Sahin Naqvi, Ph.D., and Joanna Wysocka, Ph.D., both of Stanford University; Myoung Keun Lee, Heather L. Szabo-Rogers, Ph.D., Mary L. Marazita, Ph.D., and John R. Shaffer, Ph.D., all of Pitt; Paul A. Romitti, Ph.D., of the University of Iowa; Simeon A. Boyadjiev, M.D., of the University of California, Davis; Mark D. Shriver, Ph.D., of Penn State University; and Peter Claes, Ph.D., of KU Leuven and Murdoch Children’s Research Institute.

    This research was supported by the National Institute of Dental and Craniofacial Research (R01DE027023, R01DE016886, R03DE031061 and X01HL14053) and the Intramural Research Program of the National Human Genome Research Institute, National Institutes of Health.

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  • Advances in Knee Replacement Surgery Enable More Patients to Go Home the Same Day

    Advances in Knee Replacement Surgery Enable More Patients to Go Home the Same Day

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    Newswise — Knee replacement surgery in the morning, and back home that evening? Many patients are surprised to learn it is an option. Forgoing a night in the hospital has become increasingly common, and improvements in knee replacement technology, surgical technique and pain management make it possible, says Martin W. Roche, MD, an orthopedic surgeon and director of joint replacement at HSS Florida in West Palm Beach.

    Many patients are pleased to spend the first night after surgery in the comfort of their own home, he says. “We’ve come a long way in terms of being able to get people up and out of the hospital quickly, and that motivates them mentally, as well,” he explains.

    Dr. Roche points to advances over the past five years or so that benefit patients and can lead to a faster recovery: a CT scan before surgery to create a 3D model of the patient’s knee to plan a highly personalized procedure; the use of surgical robotics and sensors that allow for a high degree of precision and accuracy; less invasive, muscle-sparing surgery performed with smaller incisions; and a program called “pre-habilitation,” in which patients begin physical therapy to get stronger prior to knee replacement.

    A longer-lasting regional nerve block and a technique known as multimodal analgesia result in better pain control after surgery − another advantage for patients wishing to leave the hospital the same day, according to Dr. Roche. The technique uses various medications that target multiple pain pathways, as needed, and generally lessens the need for opioid medications.

    The best candidates for outpatient knee replacement are highly motivated individuals in good general health who have the right home environment, including support from family, a friend or a caregiver. 

    Seventy-three-year-old Robert Fleetwood fit the bill. He was motivated to have joint replacement in both knees not only to relieve arthritis pain, but to get back to the athletic activities that were once his passion. He said he was happy to learn he was a candidate for ambulatory surgery. He had two knee replacements several months apart last year and each time went home the same day.

    Dr. Fleetwood, who lives in Stuart, says it changed his life. This year, he participated in a 1K Navy SEAL memorial open water swim, competing with many people half his age. He came in second out of participants ages 60 and up, and 30th out of about 150 swimmers. He is also back to running for exercise for the first time in more than 20 years.

    Dr. Fleetwood, who has a PhD in clinical and industrial organization psychology, travels to Atlanta about 12 times a year for work. Before the knee replacements, he dreaded all the walking at the airport. He is thrilled that he can now travel pain-free.

    “It changes your perspective on life. It makes you feel so much more alive and dynamic when you’re not living with chronic pain that becomes debilitating,” he explains. “I’m very happy now.” 

    About HSS

    HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 14th consecutive year), No. 2 in rheumatology by U.S. News & World Report (2023-2024), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2023-2024). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a fourth consecutive year (2023). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. In addition, more than 200 HSS clinical investigators are working to improve patient outcomes through better ways to prevent, diagnose, and treat orthopedic, rheumatic and musculoskeletal diseases. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

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  • Different pain types in multiple sclerosis can cause difficulty staying active

    Different pain types in multiple sclerosis can cause difficulty staying active

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    BYLINE: Valerie Goodwin

    Newswise — For patients with multiple sclerosis, a regular exercise routine is important for managing symptoms. But due to different causes of chronic pain, physical exercise can be more difficult for some.

    Research published in the Journal of Pain from the University of Michigan found that widespread pain with nociplastic features can make engaging in physical activity a painful task for patients with MS.

    “Widespread pain with nociplastic features is a chronic and diffuse pain which can be challenging to localize or describe precisely,” said Libak Abou, Ph.D., research assistant professor and lead author of the paper. 

    “In a person with MS, this type of pain arises from altered processing signals within the central nervous system. This is opposed to pain that arises from specific tissue damage, classified as nociceptive pain, or pain related to demyelination and axonal damage, classified as neuropathic pain.”

    Abou and fellow researchers surveyed patients with MS to see if those with a higher indication of widespread pain with nociplastic features were more likely to be insufficiently active or sedentary when compared to their MS counterparts with no chronic pain, nociceptive pain, or neuropathic pain.

    Each of the participants was self-reporting with their data.

    The results of the survey showed that those who experienced WPNF in addition to their MS were not sufficiently active due to the chronic pain they were experiencing.

    “There is a growing need to consider what type of pain MS patients are experiencing before giving them an exercise plan,” said Abou.

    “The concept of considering widespread pain with nociplastic features when creating exercise plans for MS is newer but could help many patients get to an activity level that will help ease symptoms without causing them intense pain.”

    For the future, Abou hopes that clinicians can begin doing screenings for underlying pain mechanisms in patients with MS that are struggling to stay active to help further tailor their physical routines to their personal needs.

    “The end goal is to help those with MS maintain their functional independence,” said Abou.

    “It is also important to remember that these patients will likely need extra support from their physical therapy team to keep them on a path with less pain.”

    Additional authors: Libak Abou, Daniel Whibley, and Anna L. Kratz from the Department of Physical Medicine and Rehabilitation, Michigan Medicine, University of Michigan, Ann Arbor, Michigan as well as the Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor, Michigan. Daniel J. Clauw from the Department of Anesthesiology, Michigan Medicine, University of Michigan, Ann Arbor, Michigan.

    Paper cited: “Widespread Pain With Nociplastic Features is an Independent Predictor of Low Physical Activity in People with Multiple Sclerosis,” The Journal of Pain. DOI: 10.1016/j.jpain.2023.09.005

     

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  • Promoting Legume Consumption and Reducing Red Meat Safely Supports Bone Health and Protein Intake

    Promoting Legume Consumption and Reducing Red Meat Safely Supports Bone Health and Protein Intake

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    Newswise — A study conducted at the University of Helsinki demonstrated that the partial substitution of red and processed meat with pea- and faba bean–based food products ensured sufficient intake of amino acids in the diet and did not negatively affect bone metabolism.

    “Decreasing the consumption of red and processed meat in the diet to the upper limit of the Planetary Health Diet while increasing the consumption of legumes cultivated in Finland, such as peas and faba beans, is safe from the perspective of protein nutrition. Similarly, bone health is not compromised by such a dietary change either,” says Docent Suvi Itkonen from the Faculty of Agriculture and Forestry.

    In the BeanMan study, 102 Finnish men followed a study diet for six weeks.

    • One group consumed 760 grams of red and processed meat per week, which accounted for 25% of the total protein intake. The amount corresponds to the average protein consumption of Finnish men.
    • The other group consumed food products based on legumes, mainly peas and faba beans, corresponding to 20% of the total protein intake. In addition, the amount of red and processed meat consumed per week in this group amounted to the upper limit of the Planetary Health Diet (200 g or 5% of the total protein intake).

    Otherwise, the study subjects followed their habitual diet but were not allowed to eat other red or processed meat or legumes than those provided by the study.

    The researchers did not find any differences between the dietary groups in markers of bone formation or resorption. Neither did the intake of calcium or vitamin D differ between the groups. Calcium intake was in line with the current dietary recommendations, and the intake of vitamin D was very close to the recommendations. Mean essential amino acid and protein intakes met the recommendations in both groups.

    “Reducing read meat consumption is extremely important in terms of environmental impact,” Itkonen notes.

    Increasingly plant-based diets are becoming more and more popular, and the recently updated Nordic Nutrition Recommendations also emphasise the restriction of meat consumption and the moderation of dairy consumption.

    “In this study, the subjects consumed dairy products as in their habitual diets, thus their calcium and vitamin D intakes were unchanged. However, in terms of bone health, it is important to bear in mind that if one reduces the amount of dairy in the diet, it is necessary to ensure the intake of calcium and vitamin D from other sources. These sources can be plant-based beverages and yoghurt-like products fortified with those nutrients or, when necessary, dietary supplements,” Itkonen points out.

    Other findings in the BeanMan study related to, among others, lipid metabolism, gut health and nutrient intakes will be published later.

    Leg4Life (Legumes for Sustainable Food System and Healthy Life – Palkokasveilla kohti kestävää ruokajärjestelmää ja terveyttä) is a multidisciplinary project funded by the Strategic Research Council of the Academy of Finland. Leg4Life aims to achieve a comprehensive societal change towards a healthier food system and climate neutral food production and consumption by increasing the use of legumes. There are five extensive work packages in the project that cover the whole food chain from field to dinner table, all researching legumes that thrive in Finnish boreal conditions.

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  • Advances in Physical Therapy Offer Unexpected Paths to Recovery

    Advances in Physical Therapy Offer Unexpected Paths to Recovery

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    Newswise — At LifeBridge Health Physical Therapy in collaboration with NovaCare Rehabilitation, individuals are discovering new and unexpected ways that physical therapy can transform their quality of life.

    “The majority of our patients are orthopedic patients, injured athletes, and people living with general aches and pains,” says Market Manager Todd Shrager, P.T., A.T.C. “But our collaboration with a national leader like NovaCare keeps us at the forefront of physical therapy research and enables the therapy team to bring an entire roster of unique services and specialists to the community.”
    The roster is indeed diverse, with services ranging from concussion management and aquatics therapy to hand therapy and vestibular rehabilitation (for patients living with inner ear disorders). But perhaps the most unique service is ReVital, the industry’s first cancer rehabilitation program, which is specially designed to help patients manage and recuperate from the often-harsh side effects of chemotherapy, radiation and surgery.

    “Our ReVital therapists are trained and certified to understand not only what cancer can do to the body, but also what cancer treatment can do,” explains Shrager. “It’s a holistic, full-body approach that’s focused on survivorship and wellness even after the patient’s treatment ends.”

    As part of the ReVital program, physical therapists work closely with the cancer care teams at Carroll, Northwest and Sinai hospitals to create a seamless, comprehensive
    care plan for each patient. It’s a level of collaboration that Shrager says is true of all LifeBridge Health Physical Therapy services.

    “There’s a wonderful continuity of care between us and our patients’ physicians at all of our locations because we are part of the LifeBridge Health family,” he says.

    Collaborative Care for Athletes
    NovaCare and LifeBridge Health have expanded their collaboration to bring medical resources to local athletes throughout the region. In addition to LifeBridge Health’s ongoing partnerships with Loyola University and Carroll County High School Athletics, the LifeBridge Health Sports Medicine team has recently become the official medical provider for The Baseball Warehouse, Pipeline Soccer Club and Baltimore Celtic Soccer Club. Together, NovaCare and LifeBridge Health will help athletes with injury prevention and treatment through physician access, athletic training, physical therapy and education.

    Heal Without the Hassle
    LifeBridge Health Physical Therapy makes recovery easier with 18 full-service locations throughout the community. Click here to find the location nearest you.

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  • Get Off on the Right Foot: Advice When Buying Back-to-School Shoes for Kids

    Get Off on the Right Foot: Advice When Buying Back-to-School Shoes for Kids

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    BYLINE: Robin Frank

    Newswise — The start of the school year means new classes, new school supplies and for many kids, new shoes. If the back-to-school shopping list includes a new pair of sneakers, it’s important to choose a shoe with good support that fits well, according to pediatric orthopedic surgeons at Hospital for Special Surgery (HSS).

    “When parents bring their children in with foot pain or an injury, the first thing I do is ask about their shoes. The problem is often inappropriate or poorly fitting footwear,” says Dr. John Blanco, who sees young patients at HSS in New York City and at HSS Long Island. “Footwear has a lot to do with how their feet function day to day, especially during athletic activities.”

    Dr. Blanco says a sneaker should fit well in terms of length and width, have good arch support, and be made of sturdy materials. “If we could make sure shoes were the right size, had proper support and were laced up appropriately, we would probably solve 80% of the basic foot problems we see in kids,” he says.

    While many people have no problem with sneakers that they buy off the shelf, a specialty store with experienced staff can measure the foot and help select the best shoe for one’s foot type, according to Dr. Blanco.

    You don’t need to spend a lot of money to get a good shoe. “The price of the sneaker has nothing to do with the quality of the shoe,” he says. “I see kids all the time with shoes that may look fancy on the outside, but you look inside and see that they don’t provide support.“

    Dr. Blanco recommends lace-up sneakers over those that use Velcro, which provides less support. He says it’s important for young people to lace up their shoes each time they put them on. “Many kids are in the habit of slipping their foot into and out of a shoe without lacing it up appropriately, and this affects the way the shoe fits,” he explains. “A loose shoe can leave a someone more prone to injury if playing a sport.” Laces should go all the way to the very top hole and be tied snugly, as properly laced shoes give more stability to the foot.

    How to Choose

    When choosing sneakers, Joseph Molony, a physical therapist and manager of the Young Athlete Program at HSS, recommends people start with a good quality name-brand shoe. You don’t need to buy a top-of-the-line luxury model, but a solid name-brand shoe will generally be well constructed of quality materials. He offers additional advice when shopping for sneakers:

    • Identify which brand fits best. Each company uses a specific foot mold when designing shoes. You may need a narrower heel, a wider toe box or a higher arch. Try on different brands to see which design is a good match for your foot structure. Once you’ve identified which one fits well, you can generally stick with that brand. 
    • The shoe should fit comfortably and snugly with no gaps between your foot and the inside of the shoe. For example, someone with a narrow foot may not do well with a shoe with a wide toe box.
    • The shoe shouldn’t be so tight that it rubs against your foot in certain spots. 
    • Your heel should not rise up out of the shoe when you walk. Even if the shoe feels comfortable, the heel should not slide up and down.
    • If you find a shoe you like in a store and it fits well, you can see if it’s available online for less money. If the color you want isn’t available in the store, you may also be able to find it online.
    • Be careful when considering soft, flexible, cross training and minimalist sneakers (if you can roll them up or twist them easily, they would generally fall into this category). While they may be comfortable and fine for some, they are not be the best choice for kids who need shoes with support.
    • Runners may want to alternate running shoes every other day since shoe materials often take some time to recover their shape. You end up buying the same number of shoes each year when you rotate them.
    • Wear the appropriate shoe for the athletic activity. Although cross-training shoes can be used for various athletic activities, many sports require specific shoes. Running shoes are not appropriate for court and field sports.

    Dr. Blanco says it’s important to retire shoes once they’re worn out. He says many teens hold on to their shoes too long. “The main problem I see is that people wear their shoes to the very end. The shoelaces are broken, their toe is ripping through the side of the shoe, the sole is worn down, but they love the shoes.”

    Once a shoe is worn out, it no longer provides the support and protection needed for day-to-day activities, let alone sports.

    About HSS

    HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 14th consecutive year), No. 2 in rheumatology by U.S. News & World Report (2023-2024), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2023-2024). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a third consecutive year (2023). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. In addition, more than 200 HSS clinical investigators are working to improve patient outcomes through better ways to prevent, diagnosis, and treat orthopedic, rheumatic and musculoskeletal diseases. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

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  • Tunable “Affibodies” Offer a New Approach to Healing Bone Fractures

    Tunable “Affibodies” Offer a New Approach to Healing Bone Fractures

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    Newswise — Instead of bulky metal plates and screws, bone fractures might someday be healed via targeted, controlled delivery of a specialized bone-growth protein.

    University of Oregon researchers have developed a system to get that protein to the site of injury and release it gradually over time. Their approach uses small proteins called affibodies, which can be specially engineered to grab onto specific other proteins and release them at different rates.

    The team reports their results in a paper published June 28, 2023 in Advanced Healthcare Materials.

    Healing is a complex biological process, with many different proteins at the site of injury aiding in regeneration. “This initial proof of concept shows we can release things at different rates, like other proteins, to mimic how the bone would naturally regenerate,” said Jonathan Dorogin, a graduate student in Marian Hettiaratchi’s lab who led the design. Hettiaratchi is an assistant professor in the UO’s Phil and Penny Knight Campus for Accelerating Scientific Impact.

    One of these many healing-related proteins is bone morphogenetic protein-2, or BMP-2. Early in development, it helps bones form. And when someone breaks a bone, cells around the site of the fracture secrete this protein to help new bone grow. Recently, scientists and doctors have been interested in giving patients infusions of BMP-2 as a treatment to hasten healing.

    But BMP-2 is so powerful that it can easily lead to off-target effects, causing bone growth where it’s not wanted and leading to unexpected complications.

    Hettiaratchi and her colleagues have been trying to develop a more controlled strategy. Affibodies piqued the lab’s interest as a possible solution because they’re small and relatively simple to engineer, Hettiaratchi said. These molecules are cousins to antibodies, immune system molecules that selectively latch onto bacteria or viruses. But affibodies’ pared-down size makes them easier to generate in the lab. And because they’re engineered to be highly specific to the proteins they’re sticking to, there’s less risk of them interacting with other things they’re not supposed to in the body.

    The team screened a set of affibodies by testing how well they stuck to BMP-2, looking for molecules that would stick solidly but still release the protein under the right conditions. As candidate for further testing, they picked one affibody that stuck to BMP-2 more strongly, and another that had a weaker connection.

    They linked those affibodies with a squishy material called a hydrogel, which is often used as a delivery vehicle in the body for BMP-2 and similar treatments. Then, they tested how the whole package behaved in a liquid solution that mimics the environment inside the body.

    Adding affibodies to the hydrogel made it release BMP-2 more slowly than an affibody-free hydrogel, the researchers found. And changing up the affibodies could alter the rate of release, too.

     “Our innovation has been to control when the protein comes out,” Dorogin said.  

    In collaboration with colleagues in the lab of Knight Campus researcher Parisa Hosseinzadeh, the team also used machine learning to better understand how the affibodies were interacting with BMP-2.

    Hettiaratchi and Dorogin anticipate the work will be most useful for severe or complex fractures, where there’s a higher likelihood of a bone not healing correctly. They’ve filed a patent for the design of this BMP-2 delivery strategy, and are moving on to further testing with the hopes that someday, this tunable approach could be used in human patients. 

    They see affibodies as far more than just a platform for BMP-2 delivery, though. Healing is complicated, and the natural process involves a cascade of different molecules rushing to the site of injury at different times and in different quantities.

    Hettiaratchi ultimately envisions an affibody-based system that could deliver many healing-related proteins to the site of an injury, each one tuned to come in at a specific rate depending on when it’s needed during the healing process.

    “BMP-2 was a great protein to start with, because we knew it would be clinically relevant,” Hettiaratchi said. “But the long-term goal is to apply this to many things in the clinic.”

     – By Laurel Hamers, University Communications

    This research is funded in part by the Department of Defense and the National Institutes of Health. The team also received a pilot grant from the Collins Medical Trust.

    About the Knight Campus 
    The Phil and Penny Knight Campus for Accelerating Scientific Impact is a hub of discovery and innovation where teams of world-class bioengineers and bioscientists are driving groundbreaking scientific research and providing an innovative approach to technical training, professional development, and entrepreneurship. Made possible by a $500 million lead gift from Penny and Phil Knight in 2016 and a second $500 million gift in 2021, the Knight Campus is home to several research centers of excellence and offers a Ph.D. in bioengineering, a bioengineering minor and an accelerated master’s degree program with multiple industry focused tracks. 

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  • HIV patients can safely undergo hip replacement, study finds

    HIV patients can safely undergo hip replacement, study finds

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    Newswise — DALLAS – July 26, 2023 – Hip replacement surgery is safe for patients living with human immunodeficiency virus (HIV), researchers at UT Southwestern Medical Center found.

    Total hip arthroplasty (THA) is a common procedure performed primarily on older patients suffering from osteoarthritis or osteonecrosis, painful conditions that severely limit mobility and lifestyle choices. But some surgeons have been hesitant to perform THAs on patients with HIV or AIDS due to concerns about complications, including higher risk of infection, need for revision surgery, and increased length of hospital stay.

    “Patients living with HIV are at a higher risk for orthopedic-related diseases such as osteoarthritis or osteonecrosis of the hip due to changes in their bone metabolism and effects from their medication regimen,” said Senthil Sambandam, M.D., Assistant Professor of Orthopaedic Surgery, who led the study. “With improvements in HIV treatment leading to increased life expectancies, we are seeing a rise in the need for THA procedures in this patient population. Our study demonstrates that HIV-positive patients can safely undergo THA without concern for increased risk of complications and adds to the growing amount of literature that encourages surgeons to deliver appropriate medical care to a marginalized patient population.”

    Using data from the National Inpatient Sample covering 2016-2019, UTSW researchers identified 504 HIV-positive patients who underwent THAs and compared their postoperative complications to a cohort of 493 HIV-negative patients. Their findings, published in the Journal of Clinical Orthopaedics and Trauma, showed that postoperative complications such as pneumonia, periprosthetic infection, wound dehiscence (reopening), and superficial and deep surgical site infection were not significantly different between the HIV-positive and HIV-negative groups. Blood transfusion rates also were lower among the HIV-positive patients.

    The study was part of a larger effort by the Department of Orthopaedic Surgery to analyze arthroplasty complications in various subpopulations in support of UTSW’s commitment to the care of marginalized patient populations and equal treatment for every patient.

    “These are important findings because they can help alleviate worries among the medical community about treating a group of patients who are often overlooked,” Dr. Sambandam said. “It’s an important quality-of-life issue for many HIV-positive patients.”

    Other UTSW researchers who contributed to this study are Varatharaj Mounasamy, M.D., Professor of Orthopaedic Surgery; Ashish R. Chowdary, B.S., medical student; and Jack Beale, M.D., and Jack Martinez, M.D., residents in Orthopaedic Surgery.

    About UT Southwestern Medical Center  
    UT Southwestern, one of the nation’s premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes, and includes 26 members of the National Academy of Sciences, 19 members of the National Academy of Medicine, and 14 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,900 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in more than 80 specialties to more than 100,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 4 million outpatient visits a year.

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  • ¿Está listo para correr? Tome conciencia de las señales del entrenamiento excesivo

    ¿Está listo para correr? Tome conciencia de las señales del entrenamiento excesivo

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    Newswise — LA CROSSE, Wisconsin — Nos rodean las señales de advertencia en los caminos, en el trabajo y en los paquetes y equipamiento. El cuerpo también envía señales. A medida que se acerca la fecha de la carrera, se vuelve tentador redoblar los esfuerzos de entrenamiento. Lo que se convierte en el período principal para buscar señales de advertencia del exceso de entrenamiento.

    Las lesiones por exceso de entrenamiento o sobrecarga son cualquier lesión muscular o de las articulaciones, como la tendinitis o una fractura por sobrecarga, que ocurra por un traumatismo repetitivo. Por lo general, las lesiones por exceso de entrenamiento ocurren debido a los errores de técnica o entrenamiento.

    Los corredores son atletas tenaces. Cuando aumente notablemente la intensidad del entrenamiento, no ignore las señales de advertencia del cuerpo. Puede ser difícil reducir el esfuerzo e ir más despacio. Algunos problemas de exceso de entrenamiento se pueden resolver con un simple descanso, pero otros pueden convertirse en problemas más serios.

    Joel Luedke, un preparador físico del Sistema de Salud de Mayo Clinic de La Crosse, Wisconsin, explica las lesiones por exceso de entrenamiento y da consejos para evitarlas:

    Correr muy rápido, ejercitarse por mucho tiempo o simplemente hacer el mismo tipo de actividad en exceso puede provocar un esguince en los músculos y derivar en una lesión por sobrecarga. La técnica incorrecta también produce un impacto negativo en el cuerpo. Por ejemplo, si usas una técnica mala para correr o hacer ejercicios de fortalecimiento muscular, podrías sobrecargar ciertos músculos y provocar una lesión.

    Por suerte, la mayoría de las lesiones por sobrecarga se pueden evitar. Estas son algunas sugerencias para evitarlas:

    • Use técnicas y equipamiento adecuados.
      Ya sea que empieza una actividad nueva o practica un deporte hace mucho tiempo, tomar clases puede darle garantías de que usa la técnica correcta. Consulte a un experto sobre las técnicas adecuadas, el equipamiento y la ropa ideal para garantizar el éxito.
    • Mantenga el ritmo.
      Confíe en su rutina de entrenamiento, la cual debe distribuir la actividad aeróbica a lo largo de la semana. Tómese el tiempo para precalentar antes de hacer actividad física y enfriar después de terminar.
    • Aumente progresivamente el nivel de actividad.
      Si quiere cambiar la intensidad o la duración de la actividad física, hágalo progresivamente. No intente aumentar ninguna actividad en más del 10 por ciento por semana. El cuerpo necesita tiempo para adaptarse al nuevo esfuerzo.
    • Varíe la rutina.
      En lugar de concentrarse en un tipo de ejercicio, incorpore variedad en la rutina de entrenamiento. Hacer distintas actividades de bajo impacto evita las lesiones por sobrecarga, ya que permite usar diferentes grupos de músculos.

    Puede ser difícil saber cuándo uno se está esforzando en el entrenamiento para mejorar constantemente y cuándo se está excediendo. Prestarle atención a la dieta, la hidratación y el sueño puede ayudarle a descubrir lo que el cuerpo le dice. Si no se recupera después de dos o tres días de actividad liviana o nula, es posible que sea momento de indagar.

    Los pies y las piernas hacen un gran esfuerzo al correr varios kilómetros, por lo que debe tener en cuenta estos problemas:

    • Las ampollas de los callos y las uñas rotas de los pies son problemas comunes del exceso de entrenamiento.
    • El dolor en la planta del pie por la madrugada puede ser un signo de fascitis plantar.
    • La tendinitis puede provocar dolor en la parte posterior del tobillo o en la parte frontal de las espinillas, lo que también se llama dolor en las espinillas.

    En general, esto se puede tratar con descanso y medicamentos para aliviar el dolor y la inflamación. Desacelere el entrenamiento. Regrese al nivel de intensidad que tenía antes del problema o considere hacer entrenamiento cruzado con ejercicios de impacto bajo o nulo, como con bicicleta fija o máquina elíptica o haciendo natación. Descanse un día más. Estos síntomas serán de corto plazo si los trata rápido y de manera apropiada.

    Si el dolor continúa o empeora a pesar del descanso, es posible que exista un problema óseo, lo que es posiblemente grave. Las reacciones o lesiones por estrés son comunes en la parte central del pie, en la altura media de la espinilla o, lo que es más preocupante, en la parte alta de la pierna cerca de la cadera. El dolor que no se va es un síntoma; por eso, consulte a su equipo de atención médica.

    Informe a su equipo de atención médica si cambió recientemente la técnica de entrenamiento, la intensidad, la duración, la frecuencia o los tipos de ejercicios. Identificar la causa de la lesión por sobrecarga le ayudará a corregir el problema y evitar repetirlo. Puede buscar más información consultando a los especialistas, tales como médicos del deporte, preparadores físicos y fisioterapeutas.

    Después de que se haya curado la lesión, consulte a su equipo de atención médica para comprobar que recuperó por completo la fuerza, el movimiento, la flexibilidad y el balance antes de empezar a hacer actividad de nuevo. Preste atención a la técnica adecuada para evitar lesiones en el futuro.

    No deje que una lesión por sobrecarga le impida hacer actividad física. Si trabaja con su equipo de atención médica, le presta atención al cuerpo y mantiene el ritmo, puede evitar este inconveniente común y aumentar el nivel de actividad de manera segura.

    Reconocer que trabajó duro para prepararse complementará su sensación de satisfacción el día de la carrera, pero no se exceda. Ya casi llega. Cuídese para poder seguir corriendo con solidez hasta la línea de llegada.

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    Sistema de Salud de Mayo Clinic
    El Sistema de Salud de Mayo Clinic tiene presencia física en 44 comunidades y está conformado por 53 clínicas, 16 hospitales y otros centros que atienden las necesidades de atención médica de las personas de Iowa, Minnesota y Wisconsin. Los profesionales comunitarios de atención médica, combinados con los recursos y la experiencia de Mayo Clinic, permiten a los pacientes de la región recibir la atención médica física y virtual de más alta calidad cerca de casa.

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  • Significant variations in hip fracture health costs and care between NHS hospitals and regions, study finds

    Significant variations in hip fracture health costs and care between NHS hospitals and regions, study finds

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    Newswise — There are significant variations in healthcare spending and care delivery across NHS hospitals in England and Wales following hip fracture, a new study aimed at understanding how hospital care impacts patients’ outcomes and costs has revealed. 

    The study, led by the University of Bristol and funded by Versus Arthritis, highlights the urgent need for evidence-based quality improvement strategies to reduce healthcare spending and improve patient outcomes in the year following a hip fracture.  The research is published online in The Lancet Healthy Longevity today [10 July].

    Hip fracture is a serious health concern, with more than 70,000 older adults admitted to a UK hospital each year. This study highlights the high healthcare burden associated with breaking a hip.

    The research analysed data from national databases for 178,757 hip fracture patients aged 60 years and above in England and Wales, who broke their hip between 2016 and 2019, followed up to just before the pandemic. More than one in four patients died within a year of their hip fracture.

    Patients spent an average of 32 days in hospital in the year following a hip fracture, resulting in substantial inpatient costs of on average £14,642 per patient – a cost similar to that incurred in the year after a stroke, and that exceeds costs of many common cancers. But this cost varied substantially between hospitals, with more than a two-fold difference in spending, ranging from £10,867 to £23,188 per patient, between 172 NHS hospitals studied in England and Wales.

    The researchers identified that in hospitals where patients are up and about quickly after their operation and where physiotherapy is provided seven days a week, patient costs were lower, and patients spent fewer days in hospital in the year following hip fracture.

    The research further highlighted the crucial role of orthogeriatricians – consultant geriatricians who specialise in the care of people with fractures – in hip fracture care.

    Dr Petra Baji, Senior Research Associate in Health Economics at Bristol Medical School: Translational Health Sciences (THS) and the paper’s first author, explained: “The findings suggest that having all patients assessed by an orthogeriatrician within the first days of admission could cut healthcare spending by £529 per patient, as well as reduce the chance of dying by 15% in the year following hip fracture.”

    Dr Rita Patel, Senior Research Associate in Medical Statistics at Bristol and statistician for the study, added: “If a consultant orthogeriatrician attends hospital clinical governance meetings, a further cost saving of £356 per patient could potentially be achieved, as well as patients spending fewer days spent in the hospital in the year following hip fracture.”

    “Hospitals with fracture liaison services also have lower mortality rates and patients spend fewer days in hospital. Our study suggests that rather than increasing the burden on the NHS, providing additional care for patients with orthogeriatrician and fracture liaison services may actually improve NHS efficiency.”

    The study highlights the importance of addressing the way hospitals deliver hip fracture care to improve the effectiveness and efficiency of hip fracture services, and the need to develop evidence-based quality improvement strategies across the UK, to achieve financial savings while also improving patient outcomes.

    Celia Gregson, Professor in Clinical Epidemiology in the Musculoskeletal Research Unit at the University of Bristol and Chief Investigator of the study, commented, “The variation we have seen in patient outcomes and health spending following hip fracture are difficult to justify on purely clinical grounds, it tells us that the way we organise the delivery of care can be improved nationally.

    “By prioritising orthogeriatrician assessment, getting patients out of bed promptly after surgery, providing seven-day physiotherapy, reducing delirium risk for patients, and holding monthly multidisciplinary clinical governance meetings, hospitals stand to improve patient outcomes and reduce their healthcare spending.”

    Caroline Aylott, Head of Research Delivery at Versus Arthritis, said: “This research shows the unacceptable state of care for older people who break their hip. The findings show that older people have a high chance of dying within a year of a hip fracture, and that quality of care varies hugely between NHS hospitals in England and Wales.

    “As hip fractures mainly affect older people, many of whom live with multiple long-term conditions, this research suggests we are not getting older people’s care right. That must change.

    “The study found that better, faster access to orthogeriatricians and fracture liaison services would not only reduce people’s risk of dying and improve chances of a better recovery, but also reduce NHS spending. Just weeks after publication of the NHS workforce plan, the study provides yet further evidence of the desperate and immediate need for a properly resourced NHS.”

    The research team has already developed a potential solution, after working with the Royal Osteoporosis Society to develop an innovative toolkit – REDUCE hip fracture service implementation toolkit – informed by the results of their research.

    The toolkit is freely available to all healthcare professionals and service managers to support the quality improvement of fracture service provision within the 172 acute hospital settings across England and Wales.

    This study follows previous work from the REDUCE study (REducing unwarranted variation in the Delivery of high-qUality hip fraCture services in England and Wales), published last year in Age and Ageing, the journal of the British Geriatrics Society, which focused on patient outcomes of hip fracture patients in the short term.

    The study was funded by Versus Arthritis (ref: 22086), the UK’s biggest charity supporting people with arthritis and musculoskeletal conditions, and supported by the National Institute for Health and Care Research Bristol Biomedical Research Centre (NIHR Bristol BRC).

    Paper

    ‘Organisational factors associated with hospital costs and patient mortality in the 365 days following hip fracture in England and Wales (REDUCE): a record-linkage cohort study’ by Petra Baji, Elsa M R Marques, Celia L Gregson et al. in The Lancet Healthy Longevity [open access]

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  • Bilateral total knee arthroplasty linked to increased complication rates

    Bilateral total knee arthroplasty linked to increased complication rates

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    Newswise — July 7, 2023 – Patients undergoing bilateral total knee arthroplasty (TKA) are at an increased risk of several types of complications, as compared with matched patients undergoing unilateral TKA, reports a study in The Journal of Bone & Joint Surgery. The journal is published in the Lippincott portfolio in partnership with Wolters Kluwer.

    “Patients who underwent simultaneous bilateral TKA were at higher risk of experiencing postoperative complications such as pulmonary embolism, stroke, blood loss anemia, and requiring a transfusion,” according to the report by Nathanael D. Heckmann, MD, and colleagues of Keck School of Medicine of USC, Los Angeles.

    Study in matched groups of patients clarifies risks of bilateral TKA

    TKA is a highly effective treatment for patients with advanced osteoarthritis of the knee, decreasing pain and improving function. When both knees are affected, bilateral TKA offers some advantages over sequential unilateral TKA, including less time in the hospital, a single rehabilitation period, and lower overall costs.

    However, some studies have found an increased risk of complications, along with a higher mortality rate, in patients undergoing bilateral TKA. These studies have had important limitations, including a lack of patient matching to account for potential differences between those undergoing  bilateral versus unilateral TKA. To address these issues, Dr. Heckmann and colleagues compared complications and mortality in a large, nationally representative group of patients undergoing bilateral versus unilateral TKA.

    The analysis included more than 21,000 patients undergoing simultaneous bilateral TKA. These were matched for age, sex, race, and comorbidities with a cohort of 126,000 patients undergoing unilateral TKA. After matching, the two groups had an average age of 64 years with similar comorbidities. As all TKAS were performed between 2015 and 2020, the surgical procedures reflected modern orthopaedic practice.

    Stroke, transfusion, and other risks higher following bilateral TKA

    Patients in the simultaneous bilateral TKA group had increased rates of several types of complications compared with those in the unilateral TKA group, pulmonary embolism (0.27% versus 0.13%), stroke (0.13% versus 0.06%), and respiratory failure (0.46% versus 0.34%).

    Patients undergoing bilateral TKA were also at a higher risk of anemia due to blood loss (26.89% versus 14.86%) and were more likely to undergo a blood transfusion (5.23% versus 0.67%). These risks were increased despite the high use of tranexamic acid to reduce blood loss during surgery in both groups.

    Patients undergoing bilateral TKA were also more likely to be readmitted to the hospital within 90 days (2.80% versus 2.05%). There was no significant increase in the risk of in-hospital death (0.05% versus 0.04%).

    After adjusting for confounders, the risks of pulmonary embolism, stroke, and acute blood loss anemia were approximately doubled in the bilateral TKA group, while the risk of blood transfusion was nearly nine times higher. The risk of readmission within 90 days was 35% higher with bilateral compared with unilateral TKA.

    “This study presents the largest matched sample size to date comparing the complications and safety between patients treated with simultaneous bilateral TKA and those treated with unilateral TKA,” Dr. Heckmann and coauthors write. Although there was no significant difference in the rate of in-hospital death, “The risk of mortality following simultaneous bilateral TKA is still a topic of concern.” The researchers emphasize the need for patient counseling and “thorough medical optimization” in patients selected for bilateral TKA.

    Read [Complications and Safety of Simultaneous Bilateral Total Knee Arthroplasty: A Patient Characteristic and Comorbidity-Matched Analysis]

    Wolters Kluwer provides trusted clinical technology and evidence-based solutions that engage clinicians, patients, researchers and students in effective decision-making and outcomes across healthcare. We support clinical effectiveness, learning and research, clinical surveillance and compliance, as well as data solutions. For more information about our solutions, visit https://www.wolterskluwer.com/en/health and follow us on LinkedIn and Twitter @WKHealth.

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    About The Journal of Bone & Joint Surgery

    The Journal of Bone & Joint Surgery (JBJS) has been the most valued source of information for orthopaedic surgeons and researchers for over 125 years and is the gold standard in peer-reviewed scientific information in the field. A core journal and essential reading for general as well as specialist orthopaedic surgeons worldwide, The Journal publishes evidence-based research to enhance the quality of care for orthopaedic patients. Standards of excellence and high quality are maintained in everything we do, from the science of the content published to the customer service we provide. JBJS is an independent, non-profit journal.

    About Wolters Kluwer

    Wolters Kluwer (EURONEXT: WKL) is a global leader in professional information, software solutions, and services for the healthcare, tax and accounting, financial and corporate compliance, legal and regulatory, and corporate performance and ESG sectors. We help our customers make critical decisions every day by providing expert solutions that combine deep domain knowledge with specialized technology and services.

     Wolters Kluwer reported 2022 annual revenues of €5.5 billion. The group serves customers in over 180 countries, maintains operations in over 40 countries, and employs approximately 20,000 people worldwide. The company is headquartered in Alphen aan den Rijn, the Netherlands.

    For more information, visit www.wolterskluwer.com, follow us on LinkedIn, Twitter, Facebook, and YouTube.

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    Wolters Kluwer Health: Lippincott

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