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2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. -. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Although ACL reconstruction is effective, the procedure has drawbacks; the . National Library of Medicine Commonly, they occur in a non-contact fashion with an acute twisting of the knee. So as the ACL cells move into the implant, they absorb the protein of the implant and replace it with new protein organized like the native ACL, she tells Verywell. So far, so good, Fleming reports. BEAR: An Innovative Solution for an ACL Tear Patients report more satisfaction in terms of pain, symptoms, and readiness. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year - PubMed (7) Bczkowicz D, Skomudek A. Recruitment for the BEAR II trial was initiated in May 2015, and enrollment was completed June 2016. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. (8) Nyland J, Klein S, Caborn DN. The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. PDF Bridge-Enhanced Anterior Cruciate Ligament Repair: The Next Step Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. The bodys own tissue eventually replaces the implant. The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. 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. 2009;17(2):162169. Am J Sports Med. I am confident that it is a viable alternative to ACL reconstruction as it does not require graft harvest, it does not compromise muscle function, and there is evidence in preclinical models that the procedure reduces arthritis,a long-termproblem associated with ACL reconstruction surgery, he says. 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. About Miach Orthopaedics, Inc. Am J Sports Med. 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. Commercial Availability of BEAR Implant - Miach Orthopaedics Despite minor improvements to the procedure, clinical outcomes have not really changed. 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. 2023;9:8. doi: 10.1051/sicotj/2023007. Kristen Fischer is a journalist who has covered health news for more than a decade. A new absorbable device known as the Bridge-Enhanced ACL Repair (BEAR) was approved by the Food and Drug Administration (FDA) to repair some anterior cruciate ligament (ACL) injuries. National Library of Medicine Share this article. Thats the Regenexx Perc-ACLR procedure (Percutaneous ACL Repair). The American Journal of Sports Medicine. 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). Using the BEAR implant, no other structures in the body need to be compromised in order to harvest a graft to replace the injured ligament. has patents/patents pending for the BEAR technology from Boston Childrens Hospital and Rhode Island Hospital, is a paid associate editor for The American Journal of Sports Medicine, has received royalties from Springer, and has received research grants from the NIH and the Department of Defense. Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. 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. -, Arneja S, Leith J. Study design: Magnetic resonance imaging from the 7 patients in the anterior cruciate ligament reconstruction (ACLR) group at 24 months shows an intact graft between the femoral and tibial tunnels (arrows). Disclaimer. Today, the U.S. Food and Drug Administration granted marketing authorizationunder the De Novo premarket review pathwayfor an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. December 16, 2020. 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. Updated December 16, 2020. AOSSM checks author disclosures against the Open Payments Database (OPD). Disclaimer. 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 . The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. 2020 08:00 AM Eastern Standard Time. If the latter holds true in clinical patients, then the impact of the BEAR procedure will be even greater.. Before Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. 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. Epub 2013 Aug 19. Dont wait. Patients received physical therapy and were followed for two years. 2023;9:8. doi: 10.1051/sicotj/2023007. Epub 2023 Jan 13. Am J Sports Med. Patients were randomly assigned to receive either BEAR (n = 65) or autograft ACLR (n = 35 [33 with quadrupled semitendinosus-gracilis and 2 with bone-patellar tendon-bone]). 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). Epub 2018 Jul 22. Miach Orthopaedics' Bridge-Enhanced ACL Repair (BEAR) Implant has received marketing approval for the treatment of anterior cruciate ligament tears. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Background: This study assessed the safety of the newly developed bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR), which involves suture repair of the ligament combined with a bioactive scaffold to bridge the gap between the torn ligament ends. official website and that any information you provide is encrypted However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. In Complete ACL Tears, Bridge-Enhanced ACL Repair Was Noninferior to ACL Reconstruction for Symptoms and Functioning and Knee Laxity at 2 Years. Epub 2020 Jun 25. The BEAR Implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). J Bone Joint Surg Am. Schematic of the technique used to place the BEAR implant. 2023 Mar;51(3):NP12-NP14. Her discoveries led to the conceptualization of an implant that could be placed between the torn ends of the ACL to bridge the gap, which is then mixed with the patients own blood to stimulate healing. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). Study design: 2021 Feb 3;103 (3):e14. 8600 Rockville Pike Third, while its unknown if knees repaired with BEAR retain their position sense, thats much more likely than the tendon graft placed by ACLR surgery. Schematic of the technique used to place the BEAR implant. Am J Sports Med. 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. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. J Exp Orthop. Epub 2019 Dec 19. Lifespan, Rhode Island's first health system, was founded in 1994 by Rhode Island Hospital and the Miriam Hospital. The peripheral higher signal intensity (lighter gray) indicates increased higher water content in the tissues surrounding the repaired ACL. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. These promising results suggest that longer-term studies of this technique are justified. 2010 Sep;26(9):1212-25. doi: 10.1016/j.arthro.2010.01.003. "This is very novel. Federal government websites often end in .gov or .mil. 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. 2013 Jun 28;15(3):205-14. doi: 10.5604/15093492.1058410. 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. She said it had the potential to change the standard of care.. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). 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. Batista JP, Maestu R, Barbier J, Chahla J, Kunze KN. eCollection 2023 Apr. Federal government websites often end in .gov or .mil. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. 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). Lower extremity compensatory neuromuscular and biomechanical adaptations 2 to 11 years after anterior cruciate ligament reconstruction. eCollection 2019 Mar. Epub 2023 Apr 13. 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. 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. Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. Dr. Fadale: ACL tears are among the most common knee injuries. Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. Cohort study; Level of evidence, 2. It can also be done via sutures, a medical device used to hold body tissues together. 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. J Pain Res. The https:// ensures that you are connecting to the This double-bundle design ensures that the ACL can control the rotation of the tibia, an essential function in protecting the knee. To learn more about the BEAR-MOON trial or to schedule an appointment with a trial physician, email bear.trial@lifespan.org or call 1-401-649-1906. 2023 Feb 20;24(1):8. doi: 10.1186/s10195-023-00688-5. In total, 96% of the patients returned for 2-year follow-up. Bridge-Enhanced ACL Repair (BEAR) | Lifespan 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.
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