-, Andernord D, Desai N, Bjornsson H, Ylander M, Karlsson J, Samuelsson K. Patient predictors of early revision surgery after anterior cruciate ligament reconstruction: a cohort study of 16,930 patients with 2-year follow-up. BEAR may result in knee stability and patient-reported outcomes at 2 years sufficient to warrant longer term studies of efficacy in larger groups of patients. Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . However, given that BEAR is a new technology, most surgeons are unlikely to allow a return to sports at six months. and transmitted securely. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial. 2 nonabsorbable sutures (green sutures) and No. Find a Surgeon. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. When the trial showed that no major complications occurred, the FDA granted approval for a second study (BEAR II) comparing outcomes of patients receiving BEAR to those receiving ACL reconstruction graft (the gold standard). Am J Sports Med. Bethesda, MD 20894, Web Policies This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. Additional stitching holds the device in place. Thank you, {{form.email}}, for signing up. AOSSM checks author disclosures against the Open Payments Database (OPD). The relationships among isometric, isotonic, and isokinetic concentric and eccentric quadriceps and hamstring force and three components of athletic performance. Barnett SC, Murray MM, Badger GJ; BEAR Trial Team; Yen YM, Kramer DE, Sanborn R, Kiapour A, Proffen B, Sant N, Fleming BC, Micheli LJ. Background: While a sex effect on outcomes following anterior cruciate ligament (ACL) reconstruction surgery has been previously documented, less is known following bridge-enhanced ACL repair (BEAR). So hopefully, well see more ACL repair than tendon grafts in the near future! 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3. . U.S. Food and Drug Administration. Recovery will take months, and re-tearing is common in active individuals. For the BEAR Trial Team, B.P. Registration: AR065462 and R01AR056834). (17) Centeno CJ, Pitts J, Al-Sayegh H, Freeman MD. (B) The scaffold is then saturated with 5 to 10 mL of the patients blood, and (C) the tibial stump is pulled up into the saturated scaffold. Knee extension and flexion muscle power after anterior cruciate ligament reconstruction with patellar tendon graft or hamstring tendons graft: a cross-sectional comparison 3 years post surgery. In my experience, about 1/3 of all complete ACL tears are retracted (BEAR candidate), and about 2/3rds are non-retracted (Regenexx Perc-ACLR candidate). 2006;34(1):128135. Dont wait. Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive. Study design: 2013 Jun 28;15(3):205-14. doi: 10.5604/15093492.1058410. Am J Sports Med. J Exp Orthop. 2019 Mar 22;7(3):2325967118824356. doi: 10.1177/2325967118824356. M.M.M. Murray points out that patients who incurred an ACL months ago or who have little ACL tissue left would be more likely to benefit from an ACL reconstruction, rather than this implant. Annually in the United States, as many as 250,000 people suffer an ACL tear [2 . Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Health's Office of Orthopedic Devices. Li J, Rothrauff B, Chen S, Zhao S, Wu Z, Chen Q, He J. Orthop J Sports Med. Further work is planned The bodys own tissue eventually replaces the implant. The BEAR Implant is indicated for skeletallymature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. At two years, control subjects had a laxity that, on average, was greater by 1.8 mm in the treated knee than that of the untreated knee. 1991;14(3):114120. To learn more, see my video below: Our research has shown that for the right type of tears, you end up with MRI and functional evidence of a repaired ACL. 2023;9:8. doi: 10.1051/sicotj/2023007. Perhaps the single biggest question from an athlete is, When can I return to play? For ACL surgery, the current recommendations are 1-2 years. The intact fibers have low signal intensity (black), reflecting highly organized tissue with little free water. Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Background: Orthop J Sports Med. Whether it replaces ACL reconstruction as the gold standard remains to be seen but I am optimistic it will, Fleming adds. 2023;9:8. doi: 10.1051/sicotj/2023007. 8600 Rockville Pike Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. There are four primary goals to ACL repair using the BEAR Implant: Provide a stable knee. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. eCollection 2021 Nov. Barnett S, Badger GJ, Kiapour A, Yen YM, Henderson R, Freiberger C, Proffen B, Sant N, Trainor B, Fleming BC, Micheli LJ, Murray MM, Kramer DE. Am J Sports Med. The signal intensity within the graft is variable. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. Thus, there remains a need to find a new method that is less invasive and has the potential to provide better outcomes. This is a potential problem as the natural ACL has two bands that cross each other (hence the name Cruciate, which in Latin means cross). However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. Arthrometry measures the difference in laxity between a person's healthy leg and their injured leg. Lifespan, Rhode Island's first health system, was founded in 1994 by Rhode Island Hospital and the Miriam Hospital. When a patient tears the Anterior Cruciate Ligament (ACL) in the knee and physical therapy cannot return that individual to sports, ACL reconstruction surgery (ACLR) is usually the next step. National Library of Medicine Lets look at the positives and negatives of this new technology and compare it to the Regenexx perc-ACLR procedure. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. Would you like email updates of new search results? ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. B.C.F. Results: -, Astur DC, Cachoeira CM, da Silva Vieira T, Debieux P, Kaleka CC, Cohen M. Increased incidence of anterior cruciate ligament revision surgery in paediatric verses adult population. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. In 2020 Murray et al reported the outcome results of their Level I randomized-controlled trial examining a similar cohort of patients . Its an absorbable implant thats derived from bovine collagena naturally occurring protein present in the connective tissue. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Healths Office of Orthopedic Devices, Todays marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.. 2021 Apr;29(4):518-526. doi: 10.1016/j.joca.2021.01.004. from 8 AM - 9 PM ET. It is recommended that the BEAR device be implanted within 50 days of injury. The American Journal of Sports Medicine. Careers. Dr. Hulstyn: Female athletes are at 2-8 times greater risk of primary ACL injury compared with males, even when controlling for sport and competition level. Patients must have an ACL stump attached to the tibia to construct the repair. BEAR is a new technique that uses a collagen scaffold instead of a graft to repair the ACL. Conclusion: -. National Library of Medicine The BEAR Implant is indicated for skeletallymature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. In addition, 14% of the BEAR group and 6% of the ACLR group had a reinjury that required a second ipsilateral ACL surgical procedure (P = .32). 2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. official website and that any information you provide is encrypted 2014;42(7):1567-1573. doi:10.1177/0363546514530088. J Pain Res. Please enable it to take advantage of the complete set of features! HHS Vulnerability Disclosure, Help One hundred patients (median age, 17 years; median preoperative Marx activity score, 16) with complete midsubstance ACL injuries were enrolled and underwent surgery within 45 days of injury. Despite being a very common injury, until today, the only surgical treatment available for torn ACLs has been ACL reconstruction using allograft, autograft or suture-only repair. Murray, M, et al. PMID: 26261424; PMCID: PMC4527573. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001). Arthroscopy. Patients who had a bridge-enhanced ACL repair technique showed similar patient-report outcomes with no infection or rejection compared with patients who had autograft ACL reconstruction, according . Murray MM, Fleming BC, Badger GJ; BEAR Trial Team; Freiberger C, Henderson R, Barnett S, Kiapour A, Ecklund K, Proffen B, Sant N, Kramer DE, Micheli LJ, Yen YM. Because ACLs do not repair themselves, the surgeon typically uses a tendon graft from another part of the patients body to replace the ACL. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. Epub 2019 Dec 19. 2009;17(2):162169. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. 2016;44(7):16601670. all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. 2010 Sep;26(9):1212-25. doi: 10.1016/j.arthro.2010.01.003. 2023 Mar;51(3):NP12-NP14. L.J.M. What is it? The FDA granted marketing authorization for an implant to repair the injury. The Bridge-Enhanced ACL Repair (BEAR) Implant is an alternative to ACL reconstruction, which typically requires harvesting tendonsand sometimes bonefrom another part of the patients body or a deceased donor. The BEAR Implant is different because it works with . However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. This difference in injury risk is an important focus of research and has been attributed to anatomy, hormonal effects, neuromuscular control, biomechanics, and sport participation. Benefits of BEAR ACL Repair in Pediatric Patients. Meaning these patients return to sports just like those who get ACLR surgery. Dr. Fleming: ACL reconstruction surgery in active patients has been the gold standard treatment for more than three decades. B.L.P. ACLR, anterior cruciate ligament reconstruction; AP, anteroposterior; BEAR, bridge-enhanced anterior cruciate ligament repair; BPTB, bonepatellar tendonbone; IKDC, International Knee Documentation Committee; PE, physical examination; ROM, range of motion. -, Ageberg E, Roos HP, Silbernagel KG, Thomee R, Roos EM. Epub 2021 Feb 4. The https:// ensures that you are connecting to the Fleming says it will be interesting to see if the rate of arthritis following implant insertion will be less than in patients receiving ACL reconstruction as the teams preclinical studies suggest. The BEAR Implant was cleared by the U.S. Food & Drug Administration through the De Novo Pathway. Most of these injuries happen to non-professional athletes. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the bodys own tissue. Lu W, Deng Z, Essien AE, Arthur Vithran DT, Opoku M, Li Y, Xiao W. J Clin Med. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing. Epub 2016 May 13. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. December 16, 2020. The surgery, however, is not without its problems. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL . Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. Martha Murray, MD, an orthopedic surgeon at Boston Childrens Hospital and professor at Harvard Medical School who spearheaded the research, notes that the implantis made of the same proteins found in the normal ACL. Federal government websites often end in .gov or .mil. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human; scaffold-enhanced ACL repair. Unauthorized use of these marks is strictly prohibited. The purpose of this study was to report the 12- and 24-month outcomes of patients who underwent the BEAR procedure compared with a nonrandomized concurrent control group who underwent ACL reconstruction (ACLR) with an autograft. It doesnt require a second wound site to remove healthy tendon and does not involve donors. The primary objective of the BEAR I trial was to show that there would be no major complications (i.e., inflammation, infection, or rejection) in patients who received the implant. is a founder, paid consultant, and equity holder in Miach Orthopaedics, Inc, which was formed to work on upscaling production of the BEAR scaffold. Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. 8600 Rockville Pike And as it stands, implant recipients shouldnt return to a sport for nine months after their surgery, which is similar to traditional ACL reconstruction, Fleming says. sharing sensitive information, make sure youre on a federal Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. "Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon and bone from other parts of the body, or obtained from a tissue bank, to complete the reconstruction," said Capt. Epub 2020 Apr 16. In order to classify the BEAR (Bridge-Enhanced ACL Repair) Implant into class I or II, it is necessary that the government site. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. Patients were unblinded after their 2-year visit. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. Upper left panel: A suture (purple) is placed through the tibial stump via a whipstitch and secured with 2 free sutures (green) to an extracortical button. Epub 2023 Jan 16. 2016 Oct;44(10):2579-2588. doi: 10.1177/0363546516655333. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. Despite this, the young and active population that BEAR was tested had excellent outcomes that were at least as similar as those receiving ACL reconstruction.. The typical treatment for this injury is reconstructive surgery. Miach Orthopaedics Inc., a privately held company dedicated to developing bio-engineered surgical implants for connective tissue repair, today announced that the U.S. Food & Drug Administration has granted the company's De Novo Request for the Bridge-Enhanced ACL Repair (BEAR) Implant, resulting in marketing approval for the treatment of anterior cruciate ligament (ACL) tears, one of the . Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. has received educational support and hospitality payments from Kairos Surgical. "ACL reconstruction is one of the most common procedures in sports medicine," said . All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. The advantages are: In past decade, we have published two MRI analysis case series demonstrating good healing of the ACL with the Perc-ACLR procedure (16,17). The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. Meaning the cartilage destruction markers after an ACL reconstruction surgery are similar to those seen right after the original injury, causing a double hit to the cartilage. PMID: 30737199. Although ACL reconstruction is effective, the procedure has drawbacks; the . Clipboard, Search History, and several other advanced features are temporarily unavailable. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. The BEAR Implant is a resorbable implantmeaning it is absorbed by the bodymade from bovine collagen and is secured via suture to bridge the gap between the torn ends of a patient's ACL. The International Knee Documentation Committee subjective knee evaluation form: normative data. That's a big deal, because until now your ACL would have been replaced with either another tendon from your body or a tendon from a deceased donor. About Miach Orthopaedics, Inc. 2023 Feb;17(1):12-21. doi: 10.1177/18632521221149059. Historically, the repair method of just suturing the two ends together has not been very effective.". The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. ACL tears are often treated with surgery called ACL reconstruction. Results: The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). These results were key to receiving FDA clearance for the BEAR implant in December of 2020. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? Unauthorized use of these marks is strictly prohibited. 2021 Feb 17;103(4):358. doi: 10.2106/JBJS.20.02088. Keywords: Its a multi-center, randomized, clinical trial seeking adult participants with a torn ACL that has occurred within the past 50 days, who qualify for surgery. Researchers are hopeful this implant will become the new standard of care for ACL injuries. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Kristen Fischer is a journalist who has covered health news for more than a decade. The .gov means its official.Federal government websites often end in .gov or .mil. This change to our approach will greatly benefit our patients. ACL (anterior cruciate ligament) injuries. Epub 2010 Jun 16. M.M.M. eCollection 2021 Nov. Barnett S, Badger GJ, Kiapour A, Yen YM, Henderson R, Freiberger C, Proffen B, Sant N, Trainor B, Fleming BC, Micheli LJ, Murray MM, Kramer DE. Preclinical studies suggest that for complete midsubstance anterior cruciate ligament (ACL) injuries, a suture repair of the ACL augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair [BEAR]) may be a viable alternative to ACL reconstruction (ACLR). Between 2006-2012, doctors and researchers with Rhode Island Hospital, Brown University, and Boston Childrens, collaborated for a series of preclinical studies that were performed to optimize the implant, to demonstrate the safety of its use in the body, and to show that it stimulated the ACL to heal. The IKDC subjective scores in both groups improved significantly from baseline (P < .0001) at 12 and 24 months, to 84.6 17.2 in the ACLR group and to 91.7 11.7 in the BEAR group. Murray MM, Kalish LA, Fleming BC; BEAR Trial Team; Flutie B, Freiberger C, Henderson RN, Perrone GS, Thurber LG, Proffen BL, Ecklund K, Kramer DE, Yen YM, Micheli LJ. eCollection 2016 Nov. Barnett SC, Murray MM, Badger GJ; BEAR Trial Team; Yen YM, Kramer DE, Sanborn R, Kiapour A, Proffen B, Sant N, Fleming BC, Micheli LJ. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Effect of matching or overconstraining knee laxity during anterior cruciate ligament reconstruction on knee osteoarthritis and clinical outcomes: a randomized controlled trial with 84-month follow-up. A piece of hamstring or quadriceps tendon is harvested, and then graft tunnels are drilled into the femur and tibia. The BEAR procedure is a promising technique that will likely meet these goals.
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bear acl repair 2020