However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. During ACL reconstruction, an orthopedic surgeon removes your torn ACL and replaces it with a graft from another part of your leg (called an autograft) or a deceased donor (called an allograft). Clipboard, Search History, and several other advanced features are temporarily unavailable. Is the BEAR Implant Safe? 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. Barnes DA, Badger GJ, Yen YM, Micheli LJ, Kramer DE, Fadale PD, Hulstyn MJ, Owens BD; BEAR Trial Team; Flannery SW, Ecklund K, Sanborn RM, Costa MQ, Chrostek C, Proffen BL, Sant N, Murray MM, Fleming BC, Kiapour AM. There are no long-term outcome studies for ACL repairs, as far as we know, and postoperative protocols including physical therapy progression and return-to-play . First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. M.M.M. 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. Kristen Fischer is a journalist who has covered health news for more than a decade. 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. PMID: 32558951. BEAR represents a move toward a less invasive and equally effective surgical treatment for patients with ACL injuries.. Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes. Finally, the research on BEAR has shown a lower likelihood of tearing the ACL in the opposite knee, likely because the natural biomechanics are likely better preserved than ACLR surgery. Finally, returning to play is likely much quicker for a precise image-guided injection than the BEAR surgery. Conclusion: (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. Before One or more of the authors has declared the following potential conflict of interest or source of funding: This study received funding support from the Translational Research Program at Boston Childrens Hospital, the Childrens Hospital Orthopaedic Surgery Foundation, the Childrens Hospital Sports Medicine Foundation, the Football Players Health Study at Harvard University, and the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases through grants R01-AR065462 and R01-AR056834. It is a . B.L.P. The .gov means its official.Federal government websites often end in .gov or .mil. The .gov means its official. Patients must have an ACL stump attached to the tibia to construct the repair. The American Journal of Sports Medicine. Regenexx Perc-ACLR has been performed since 2012. Further work is planned The .gov means its official. The implant is resorbed by the body, usually within eight weeks. FOIA (6) Patterson MR, Delahunt E. A diagonal landing task to assess dynamic postural stability in ACL reconstructed females. 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. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. TheLifespan Orthopedics Institute is managing the only New England site, one of six across the nation, to conduct the trial with our partner physicians at University Orthopedics. Arthroscopy. Why is that an issue? Adam S. Lepley, PhD, co-director of the Michigan Performance Research Laboratory at the University of Michigan, who specializes in rehabilitation, noted that traditional ACL reconstruction focuses on rebuilding the ligament while the implant centers on repairing it. Epub 2013 Jun 28. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL . 2009;17:77-79. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial. 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. Comparable Instrumented Knee Joint Laxity and Patient-Reported Outcomes After ACL Repair: Response. M.M.M. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. The nonabsorbable sutures are threaded through the BEAR scaffold and tibial tunnel and secured in place with an extracortical button. 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. In the study, 65 patients received the BEAR Implant and 35 members of the control group received ACL reconstruction with autograft (using their own tendon from another part of the body). 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. The technique was approved by the Food and Drug Administration in late 2020 and has been used in a handful of patients at OHSU, beginning with the first case in Oregon this past February. ACLR, anterior cruciate ligament reconstruction; AP, anteroposterior; BEAR, bridge-enhanced anterior cruciate ligament repair; BPTB, bonepatellar tendonbone; IKDC, International Knee Documentation Committee; PE, physical examination; ROM, range of motion. Schematic of the technique used to place the BEAR implant. On June 4, 2020, FDA received your De Novo requesting classification of the BEAR (Bridge-Enhanced ACL Repair) Implant. Registration: ACL (anterior cruciate ligament) injuries. Patients with the implant had an average that was greater by 1.61 mm in the treated knee compared to their untreated knee. Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. 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). ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair. Epub 2021 Feb 4. The BEAR III trial was designed to evaluate the effects of age on outcomes following the BEAR procedure.