bear acl repair 2020

"Today's marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.". -, Anderson MA, Gieck JH, Perrin DH, Weltman A, Rutt RA, Denegar CR. Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. . Yang XG, Wang F, He X, Feng JT, Hu YC, Zhang H, Yang L, Hua K. Int Orthop. Recruitment for the BEAR MOON trial was initiated in September of 2021 and the study is currently underway. Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. Patients received physical therapy and were followed for two years. Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? In a randomized controlled trial of 100 people who experienced complete ACL rupture, 65 received the implant and 35 members in a control group had reconstruction via autograft, using tendon from their own bodies. Every patient underwent physical therapy after surgery, and the team followed them for two years. 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. Bridge-Enhanced ACL Repair vs ACL Reconstruction PDF December 16, 2020 - Food and Drug Administration 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. Find a Surgeon - ACL Implant and Treatment Options | BEAR Implant FDA Authorizes Marketing of New Implant to Repair a Torn ACL The American Journal of Sports Medicine. Annually in the United States, as many as 250,000 people suffer an ACL tear [2 . This is a bovine collagen implant inserted in the torn area of the ACL with sutures placed in graft tunnels. Surgery can be tailored accordingly. eCollection 2019 Mar. Am J Sports Med. More information about this clinical trial and the BEAR ACL restoration procedure is available at www.bearmoon.org. -. The nonabsorbable sutures are threaded through the BEAR scaffold and tibial tunnel and secured in place with an extracortical button. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. 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 . 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. (1) 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. 2023 Mar;51(3):NP12-NP14. 2021 Apr;29(4):518-526. doi: 10.1016/j.joca.2021.01.004. (7) Bczkowicz D, Skomudek A. Updated December 17, 2020. has equity interests in and is a consultant for MIACH Orthopaedics, a company that has licensed the BEAR scaffolding technology from Boston Childrens Hospital, which is also an equity holder in MIACH Orthopaedics; has patents/patents pending for the BEAR technology from Boston Childrens Hospital and Rhode Island Hospital; has received payment for grant review from the Musculoskeletal Transplant Foundation; receives royalties from Springer; and has research grants from the NIH, the Department of Defense, and the NFL Players Association through the Football Players Health Study. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. Patients were unblinded after their 2-year visit. "Torn ACLs are among the most common knee injuries in the United States," according to Capt. Key Takeaways. Quantitative MRI Biomarkers to Predict Risk of Reinjury Within 2 Years After Bridge-Enhanced ACL Restoration. (A) The torn anterior cruciate ligament (ACL) tissue is preserved. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001). The upshot? The Regenexx perc-ACLR procedure should be applied in patients that have a complete ACL tear, but the two ends are still connected. The BEAR group had a significantly higher mean hamstring muscle strength index than the ACLR group at 2 years (98.2% vs 63.2%; P < .001). These patients are currently being followed to determine long term outcomes. PMC Batista JP, Maestu R, Barbier J, Chahla J, Kunze KN. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months; no patients in either group had C (abnormal) or D (severely abnormal) grades. (12) Wirth W, Eckstein F, Culvenor AG, Hudelmaier MI, Stefan Lohmander L, Frobell RB. PDF Bridge-Enhanced Anterior Cruciate Ligament Repair: The Next Step Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH An erratum has been published: J Bone Joint Surg Am. 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 problem is that the recent research from Harvard shows that drilling these graft tunnels likely means a significant second severe inflammatory hit to the cartilage (2-4). Read our. 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. Preserve and heal the . The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Medical School, Harvard University or its affiliated academic health care centers, the NFL Players Association, Boston Childrens Hospital, or the NIH. Harvard Health Publishing. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. What if the anterior cruciate ligament (ACL) had the ability to repair itself? This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. Randomized controlled trial; Level of evidence, 1. Do you have a torn ACL? A total of 74 patients with acute proximal isolated ACL tears will be assigned in a 1:1 allocation ratio to either (I) ACL repair using cortical button fixation and additional suture augmentation or (II) ACL reconstruction using an all-inside autologous hamstring graft technique. M.M.M. NFL player-backed implant to fix ACL tears gets FDA De Novo This concept led to the development of the Bridge-Enhanced ACL Restoration (BEAR) Implant, a fundamental change in the approach to treating ACL injuries. Like the ACLR surgery, the BEAR implant only focuses on repairing a single bundle, so the knee is more likely to remain rotationally unstable. Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for 2009;17:77-79. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. The Bridge-Enhanced ACL Repair (BEAR) Implant is promoted as an alternative to reconstructive surgery using tendons from a patient's body or a tissue bank. The homogeneous low signal intensity (black) in some patients (eg, top row [first from left] and bottom row [second from left]) is typical of the normal in situ hamstring tendon because of highly organized connective tissue with little free water. 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). This allows for ACL repair. Despite minor improvements to the procedure, clinical outcomes have not really changed. Epub 2013 Aug 19. That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. Methods: Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. AOSSM checks author disclosures against the Open Payments Database (OPD). Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . 2009;17(2):162169. If you've torn your ACL and are interested in the new implant, you should talk to your doctors to see if you are a strong candidate for the new procedure or would be better off with an ACL reconstruction. The BEAR-MOON trial is enrolling 200 English-speaking individuals nationwide who: Our team of board-certified orthopedic sports medicine surgeons and researchers specializes in arthroscopic repair of sports-related injuries including complex knee reconstructions. 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. with the inherently same conflicts. -, Akelman MR, Fadale PD, Hulstyn MJ, et al. In this procedure, the torn ACL fibers are completely removed and replaced with the graft, which is inserted arthroscopically into large tunnels drilled into the knee. The BEAR-MOON trial addresses the question of whether this new and less invasive surgical procedure can provide non-inferior outcomes to the gold standard of treatment in terms of knee laxity, a common test to evaluate the integrity of the ACL, and patient-reported outcomes. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. Updated December 16, 2020. Hence, any implant procedure requiring tunnels to be drilled will likely harm cartilage. The ACL implant isnt a traditional device like those used in most joint repairs. Epub 2013 Jun 28. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 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. Conclusion: Adam S. Lepley, PhD, co-director of the Michigan Performance Research Laboratory at the University of Michigan, who specializes in rehabilitation, noted that traditional ACL reconstruction focuses on rebuilding the ligament while the implant centers on repairing it. During ACL reconstruction, an orthopedic surgeon removes your torn ACL and replaces it with a graft from another part of your leg (called an autograft) or a deceased donor (called an allograft). The BEAR III trial was designed to evaluate the effects of age on outcomes following the BEAR procedure. J Orthop Res. A piece of hamstring or quadriceps tendon is harvested, and then graft tunnels are drilled into the femur and tibia. We hypothesized that patients treated with BEAR would have a noninferior patient-reported outcomes (International Knee Documentation Committee [IKDC] Subjective Score; prespecified noninferiority margin, -11.5 points) and instrumented anteroposterior (AP) knee laxity (prespecified noninferiority margin, +2-mm side-to-side difference) and superior muscle strength at 2 years after surgery when compared with patients who underwent ACLR with autograft. In addition, the retear rate that were about to publish is lower for Perc-ACLR than BEAR, and most of our patients end up with a natural double-bundle repair which is less likely with BEAR. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. Finally, the research on BEAR has shown a lower likelihood of tearing the ACL in the opposite knee, likely because the natural biomechanics are likely better preserved than ACLR surgery. Because ACLs do not repair themselves, the surgeon typically uses a tendon graft from another part of the patients body to replace the ACL. BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. (6) Patterson MR, Delahunt E. A diagonal landing task to assess dynamic postural stability in ACL reconstructed females. 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 . 2021 Jun;39(6):1281-1288. doi: 10.1002/jor.24783. The surgery, however, is not without its problems. Early anterior cruciate ligament reconstruction does not affect 5 year change in knee cartilage thickness: secondary analysis of a randomized clinical trial. Epub 2020 Jun 25. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. official website and that any information you provide is encrypted Before Epub 2020 Apr 16. Careers. Measurements below 3 millimeters (mm) are considered normal. Orthop J Sports Med. Unable to load your collection due to an error, Unable to load your delegates due to an error, Stepwise demonstration of the bridge-enhanced anterior cruciate ligament repair (BEAR) technique using the scaffold. The BEAR Implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). Patients must have an ACL stump attached to the tibia to construct the repair. Epub 2016 Jul 27. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. This change to our approach will greatly benefit our patients. The International Knee Documentation Committee subjective knee evaluation form: normative data. Unauthorized use of these marks is strictly prohibited. By clicking Accept All Cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. is an assistant editor for The American Journal of Sports Medicine, the spouse of M.M.M. 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. Third, while it's unknown if knees repaired with BEAR retain their position sense, that's much more likely than the tendon graft . The site is secure. 2023;9:8. doi: 10.1051/sicotj/2023007. PMC (HealthDay)An anterior cruciate ligament (ACL) implant that offers an alternative to traditional ACL reconstruction has received marketing authorization from the U.S. Food and Drug. One or more of the authors has declared the following potential conflict of interest or source of funding: This study received funding support from the Translational Research Program at Boston Childrens Hospital, the Childrens Hospital Orthopaedic Surgery Foundation, the Childrens Hospital Sports Medicine Foundation, the Football Players Health Study at Harvard University, and the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases through grants R01-AR065462 and R01-AR056834. Would you like email updates of new search results? The BEAR Implant is different because it works with . Patients must have an ACL stump attached to the tibia to construct the repair. See this image and copyright information in PMC. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. Comparable Instrumented Knee Joint Laxity and Patient-Reported Outcomes After ACL Repair: Response. J Exp Orthop. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA Authorizes Marketing of New Implant to Repair a Torn ACL, Office of Orthopedic Devices, Office of Product Evaluation and Quality. This quicker return to play likely represents a less severe tear type for Perc-ACLR and the use of more powerful bone marrow concentrate versus whole blood for BEAR. The FDA reviewed the BEAR Implant through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. PMID: 23897997. Am J Sports Med. The caveat about using the implant is that the technique is most effective if the ligament ruptures mid-substance, or about the middle of the ligament, to provide two ends that are able to be sutured together. 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. from 8 AM - 9 PM ET. 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 patients ACL. Propensity for Clinically Meaningful Improvement and Surgical Failure After Anterior Cruciate Ligament Repair. Whether it replaces ACL reconstruction as the gold standard remains to be seen but I am optimistic it will, Fleming adds. FDA authorizes marketing of ACL implant - Medical Xpress Lower left panel: The free suture ends (green) at the tibial end of the BEAR implant (which was positioned between the 2 ends of the torn ACL) are passed through the tibial tunnel to be tied over a second extracortical button. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human; scaffold-enhanced ACL repair. and food, beverage, and travell reimbursements from 5 companies (each <$500). Patients report more satisfaction in terms of pain, symptoms, and readiness. Patients received physical therapy and were followed for two years. Lifespan, Rhode Island's first health system, was founded in 1994 by Rhode Island Hospital and the Miriam Hospital. However, whether patients experience a faster psychological recovery after BEAR than traditional ACLR is unknown. Failure rates for anterior cruciate ligament (ACL) repair are greater than those for ACL reconstruction. (5) Sanborn RM, Badger GJ, Proffen B, et al. PMID: 26261424; PMCID: PMC4527573. Murray also believes the implant will be a new gold standard for ACL repair in the future. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. ACL (anterior cruciate ligament) injuries. 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. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. For full product and risk information . A comprehensive, integrated, academic health system with The Warren Alpert Medical School of Brown University, Lifespan's present partners also include Rhode Island Hospital's pediatric division, Hasbro Children's Hospital; Bradley Hospital; Newport Hospital; Gateway Healthcare; Lifespan Physician Group; and Coastal Medical. Thats the Regenexx Perc-ACLR procedure (Percutaneous ACL Repair). Why is that an issue? Unable to load your collection due to an error, Unable to load your delegates due to an error. "This is very novel. Am J Sports Med. -, 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. PMID: 32558951. How many patients fail the BEAR implant and still need ACL reconstruction surgery? Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. Dont wait. Background: Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. Bridge-Enhanced ACL Repair (BEAR) Allows Torn ACL to Heal Itself Noninferiority criteria were met for both the IKDC Subjective Score (BEAR, 88.9 points; ACLR, 84.8 points; mean difference, 4.1 points [95% CI, -1.5 to 9.7]) and the side-to-side difference in AP knee laxity (BEAR, 1.61 mm; ACLR, 1.77 mm; mean difference, -0.15 mm [95% CI, -1.48 to 1.17]). There are no long-term outcome studies for ACL repairs, as far as we know, and postoperative protocols including physical therapy progression and return-to-play . BEAR resulted in noninferior patient-reported outcomes and AP knee laxity and superior hamstring muscle strength when compared with autograft ACLR at 2-year follow-up in a young and active cohort. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture. At two years, subjects who received the BEAR implant had a laxity that, on average, was greater by 1.7 mm (about the same as the thickness of a penny) in the treated knee than that of the untreated knee.

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