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. (13) Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. 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. 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. 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. How can you tell which type of complete ACL tear is which? ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair. The site is secure. government site. Bridge-enhanced ACL repair (BEAR) is a new FDA-approved procedure that allows a torn ACL to heal itself and does not require graft tissue to be taken from another part of the body. (2) Culvenor AG, Eckstein F, Wirth W, Lohmander LS, Frobell R. Loss of patellofemoral cartilage thickness over 5 years following ACL injury depends on the initial treatment strategy: results from the KANON trial. Because ACLs do not repair themselves, the surgeon typically uses a tendon graft from another part of the patients body to replace the ACL. has manufactured the scaffolds used in the trials at Boston Childrens Hospital and is a paid consultant and equity holder in Miach Orthopaedics at this time, as he assists with transfer of the manufacturing process to the contract manufacturing organization that Miach has engaged to do the manufacturing. Detailed Description: 2 absorbable suture (purple) is placed into the tibial stump of the ACL. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Careers. The Regenexx perc-ACLR procedure should be applied in patients that have a complete ACL tear, but the two ends are still connected. Epub 2023 Jan 16. Updated December 16, 2020. When Does a Partial ACL Tear Require Surgery? 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. Orthop J Sports Med. Dont wait. NCT02664545 (ClinicalTrials.gov identifier). These include educational payments from Kairos Surgical (D.E.K., Y.-M.Y.) In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. These patients are currently being followed to determine long term outcomes. 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 FDAs 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. Am J Sports Med. 2009;17:77-79. Key Takeaways. Osteoarthritis Cartilage. A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Early anterior cruciate ligament reconstruction does not affect 5 year change in knee cartilage thickness: secondary analysis of a randomized clinical trial.
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