(From Murray et al.). 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. 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. Epub 2023 Jan 13. These include educational payments from Kairos Surgical (D.E.K., Y.-M.Y.) Dr. Fadale: ACL tears are among the most common knee injuries. 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. 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. Bio Ortho J Vol 3(1):e29e39; October 5, 2021. 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. 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. If those that undergo the BEAR procedure return to sports faster and have lower rates of re-injury and osteoarthritis, it is definitely possible that it could become the new gold standard.. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. (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. 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 . PMID: 30176875; PMCID: PMC6122476. Bridge-Enhanced ACL Repair (BEAR) | Lifespan ACL (anterior cruciate ligament) injuries. AR065462 and R01AR056834). The patients were also measured using an arthrometer, which measures the range of movement in a joint. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. Epub 2020 Jun 25. Am J Sports Med. The patient needs to have some tissue intact after the tear for the implant to work. ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair. Federal government websites often end in .gov or .mil. How is the BEAR implant different from reconstruction? BEAR: A Bridge to Better Psychological Readiness After an ACL Injury Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. The BEAR Implant for ACL Tears - Regenexx from 8 AM - 9 PM ET. 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. PMID: 26261424; PMCID: PMC4527573. FDA authorizes marketing of new implant to repair a torn ACL. Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for Preserve and heal the . Epub 2023 Apr 13. This less invasive procedure lends itself to faster recovery of muscle strength after surgery and prevents morbidities associated with traditional grafts, such as kneeling pain or hamstring deficits. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Epub 2019 Feb 8. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. Schematic of the technique used to place the BEAR implant. "Today's marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.". eCollection 2022 Oct. See this image and copyright information in PMC. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Repair versus reconstruction for proximal anterior cruciate ligament (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. Y.-M.Y. During surgery, the patients own blood is injected into the implant to form a device-protected clot that enables the body to heal. Unable to load your collection due to an error, Unable to load your delegates due to an error. Read our. About Miach Orthopaedics, Inc. 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). 2015;43:121-127. BEAR-MOON? Bridge-Enhanced ACL Repair vs ACL Reconstruction BEAR is a new technique that uses a collagen scaffold instead of a graft to repair the ACL. This research study is approved by the FDA and funded by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. J Orthop Surg (Hong Kong). (D) The ends of the torn ACL then grow into the scaffold, which is gradually replaced by healing ligament tissue. FDA Authorizes Marketing of New Implant to Repair a Torn ACL PMID: 33549723. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year - PubMed -, 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. (10) Song EK, Seon JK, Yim JH, Woo SH, Seo HY, Lee KB. NCT02664545 (ClinicalTrials.gov identifier). The injury does not heal on its own, so ACL reconstruction is the only way to repair it. Assessment of neuromuscular control in patients after anterior cruciate ligament reconstruction. On June 4, 2020, FDA received your De Novo requesting classification of the BEAR (Bridge-Enhanced ACL Repair) Implant.
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