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. ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. B.L.P. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Within eight weeks, the body absorbs the implant and replaces it with new tissue that gets stronger over time. 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. Am J Sports Med. eCollection 2022 Oct. See this image and copyright information in PMC. The patient needs to have some tissue intact after the tear for the implant to work. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). Benefits of BEAR ACL Repair in Pediatric Patients. from 8 AM - 9 PM ET. For Your Consideration: Bridge Enhanced ACL Restoration (BEAR): Why PMID: 23962647. Effect of matching or overconstraining knee laxity during anterior cruciate ligament reconstruction on knee osteoarthritis and clinical outcomes: a randomized controlled trial with 84-month follow-up. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. 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. J Pain Res. 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. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you. Most of these injuries happen to non-professional athletes. Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for ACL (anterior cruciate ligament) injuries. Meaning the cartilage destruction markers after an ACL reconstruction surgery are similar to those seen right after the original injury, causing a double hit to the cartilage. Do you have a torn ACL? The recent trial results showed that 14% of patients required ACLR surgery despite the BEAR surgery (1). These initial studies demonstrated that even the first surgeries performed for this technique had similar outcomes to the current gold standard of ACL reconstruction with autograft tendon, and patients did not have to have a graft harvested from their leg, she says. 2016;44(7):16601670. Why? Hip Avascular Necrosis | Preservation & Replacement The site is secure. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). 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 new implant to repair a torn ACL. 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. 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. Cision Distribution 888-776-0942 Bethesda, MD 20894, Web Policies Trends in Anterior Cruciate Ligament Repair: A Bibliometric and Visualized Analysis. Conclusion: Orthop J Sports Med. In the late 1990s, Martha Murray, MD, then an orthopedic surgeon with Boston Childrens Hospital, was researching why the ACL failed to heal on its own. 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. An official website of the United States government. Murray points out that patients who incurred an ACL months ago or who have little ACL tissue left would be more likely to benefit from an ACL reconstruction, rather than this implant. FDA authorizes marketing of ACL implant - Medical Xpress Epub 2013 Aug 18. Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. PMC February 2022. doi:10.1177/23259671211070542. 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. Am J Sports Med. To learn more, see my video below: Our research has shown that for the right type of tears, you end up with MRI and functional evidence of a repaired ACL. 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. Unauthorized use of these marks is strictly prohibited. -, 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. BEAR should be applied in patients with complete retracted tears, which means that the two ends of the torn ACL dont connect and have pulled back like a rubber band. 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). (From Murray et al.). The site is secure. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. B.C.F. This site needs JavaScript to work properly. (15) Centeno C, Lucas M, Stemoer I, Dodson E. IMAGE-GUIDED INJECTION OF ANTERIOR CRUCIATE LIGAMENT TEARS WITH AUTOLOGOUS BONE MARROW CONCENTRATE AND PLATELETS: MIDTERM ANALYSIS FROM A RANDOMIZED CONTROLLED TRIAL. BEAR ACL repair technique shows promise for patients whose injuries are in the subset of ACL tears where the ACL still has some good substance after it is torn. 2 nonabsorbable sutures (green sutures) and No. The BEAR device must be implanted within 50 days of injury. We hypothesized that the BEAR group would have physical examination findings, patient-reported outcomes, and adverse events that were similar to those of the ACLR group. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. Background: Between 2006-2012, doctors and researchers with Rhode Island Hospital, Brown University, and Boston Childrens, collaborated for a series of preclinical studies that were performed to optimize the implant, to demonstrate the safety of its use in the body, and to show that it stimulated the ACL to heal.