Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not - PubMed Li J, Rothrauff B, Chen S, Zhao S, Wu Z, Chen Q, He J. Orthop J Sports Med. 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. 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 BEAR Implant is indicated for skeletallymature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Share this article. FDA Approves New Implant for ACL Tears - Verywell Health Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. This double-bundle design ensures that the ACL can control the rotation of the tibia, an essential function in protecting the knee. 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. 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. -, Akelman MR, Fadale PD, Hulstyn MJ, et al. Further work is planned 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. An official website of the United States government. 1991;14(3):114120. 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). Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. and food, beverage, and travell reimbursements from 5 companies (each <$500). 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. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. J Pain Res. 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. Only a single bundle repair of a double bundle ligament means the knee is left rotationally less stable (10), The graft tendon goes in at a steeper angle than the original ACL; hence its more likely to shear and fail (9), No working position sensors in the tendon repair of a ligament mean less position sense (6-8), High likelihood of developing arthritis/doesnt prevent arthritis (11,12), Higher chance of tearing the ACL on the other knee (13), The hamstrings or quadriceps muscles become weaker due to the graft harvest (14), A much less invasive procedure than surgery. However, the BEAR technology has the potential to transform the way we treat ACL injuries, with restoration of the native ligament and without the need to harvest a graft from another part of the knee. 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. 2017;45:97-105. Having said that, at least one study reported a higher percentage of patients in the BEAR surgery group who were more psychologically ready to return to sports at six months versus ACLR surgery (5). Two years after surgery, the outcomes of the two procedures proved to be similar in young and active patients, though the BEAR patients had better hamstring muscle strength. (11) Barenius B, Ponzer S, Shalabi A, Bujak R, Norln L, Eriksson K. Increased risk of osteoarthritis after anterior cruciate ligament reconstruction: a 14-year follow-up study of a randomized controlled trial. Outcomes-including the IKDC Subjective Score, the side-to-side difference in instrumented AP knee laxity, and muscle strength-were assessed at 2 years by an independent examiner blinded to the procedure. J Bone Joint Surg Am. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced 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. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. Researchers are hopeful this implant will become the new standard of care for ACL injuries. 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. Bridge-Enhanced ACL Repair (BEAR) | Lifespan ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair. Am J Sports Med. Results: Magnetic resonance imaging from the 9 patients in the bridge-enhanced anterior cruciate ligament repair (BEAR) group at 24 months shows intact anterior cruciate ligament (ACL) fibers from the femoral to tibial attachment sites (arrows). When I first heard about the BEAR ACL implant, I believed that the surgeon would place it in the correct spot and perhaps tack it down, meaning a far less invasive procedure than drilling graft tunnels. The BEAR implant is then injected with autologous whole blood. Review article: validity of the KT-1000 knee ligament arthrometer. Orthop J Sports Med. PMID: 23962647. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knee's natural anatomy and function. The injury does not heal on its own, so ACL reconstruction is the only way to repair it. Epub 2013 Aug 19. A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar The patients own blood is injected into the implant during the surgical implantation procedure with the intent of forming a device-protected clot that enables the bodys healing process. 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. 2009;17(2):162169. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. Dont wait. Quantitative MRI Biomarkers to Predict Risk of Reinjury Within 2 Years After Bridge-Enhanced ACL Restoration. The Lifespan Orthopedics Institute is managing the only New England . (5) Sanborn RM, Badger GJ, Proffen B, et al. Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. (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.