February 2022. doi:10.1177/23259671211070542. Before Purpose/hypothesis: The results were excellent (more on those below). In a recently published Randomized Controlled Trial (RCT), the BEAR procedure was shown to be as good or better than ACL reconstruction surgery (1). 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. 2 absorbable suture (purple) is placed into the tibial stump of the ACL. Patients report more satisfaction in terms of pain, symptoms, and readiness. 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. An official website of the United States government. FDA Authorizes Marketing of New Implant to Repair a Torn ACL Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. Clipboard, Search History, and several other advanced features are temporarily unavailable. It bridges the gap between the torn ends of a patients ACL, and the body then absorbs the implant within about eight weeks of surgery. 2016 Oct;44(10):2579-2588. doi: 10.1177/0363546516655333. Review article: validity of the KT-1000 knee ligament arthrometer. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Why? A more heterogeneous appearance is present in several patients (eg, top row [third from left]) with central low signal intensity and peripheral high signal intensity (lighter gray), indicating surrounding edema. The bridge enhanced ACL restoration (BEAR) procedure provides the ability to perform primary repair of the acutely torn ACL's via utilization of a proprietary protein based scaffold. Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. 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. 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). That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. M.M.M. 2009;17:77-79. 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 . M.M.M. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical 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. And what does it have to do with my (ouch) torn ACL (anterior cruciate ligament)? In my experience, about 1/3 of all complete ACL tears are retracted (BEAR candidate), and about 2/3rds are non-retracted (Regenexx Perc-ACLR candidate). -, Arneja S, Leith J. The BEAR Implant is a resorbable implantmeaning it is absorbed by the bodymade from bovine collagen and is secured via suture to bridge the gap between the torn ends of a patient's ACL. 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. BEAR is a new technique that uses a collagen scaffold instead of a graft to repair the ACL. 2023 Feb 20;24(1):8. doi: 10.1186/s10195-023-00688-5. 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. We think you need to have sufficient ACL tissue left to repair for the surgery with the implant to work, Murray says. FDA authorizes marketing of ACL implant - Medical Xpress So far, so good, Fleming reports. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. Dec 16, 2020, 14:53 ET. In addition, the retear rate that were about to publish is lower for Perc-ACLR than BEAR, and most of our patients end up with a natural double-bundle repair which is less likely with BEAR. Unable to load your collection due to an error, Unable to load your delegates due to an error. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. -. Am J Sports Med. When applied correctly to suitable patients, these two really shouldnt compete head to head in that they are focused on two different types of ACL injuries. . (13) Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. The Football Players Health Study is funded by a grant from the National Football League (NFL) Players Association. Am J Sports Med. 33,34 The scaffold is used to bridge the . Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH 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. How is BEAR different than ACLR surgery? 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. . PMC 90 clinic locations offering non-surgical Regenexx solutions for musculoskeletal pain. 2015;43:121-127. Scand J Med Sci Sports. Randomized controlled trial; Level of evidence, 1. PMID: 26261424; PMCID: PMC4527573. The BEAR procedure is a new and different way of thinking about the surgical approach to treating ACL injuries. 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. The BEAR Implant is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. James received a Master of Library Science degree from Dominican University. 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). Females Have Earlier Muscle Strength and Functional Recovery After Fleming says research is ongoing at Boston Children's Hospital, University Orthopedics, and Rhode Island Hospital to determine if there are specific patients that may do particularly well or may not do as well following the BEAR procedure. Am J Sports Med. This concept led to the development of the Bridge-Enhanced ACL Restoration (BEAR) Implant, a fundamental change in the approach to treating ACL injuries. 2020 08:00 AM Eastern Standard Time. PMID: 23897997. . First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. Like the ACLR surgery, the BEAR implant only focuses on repairing a single bundle, so the knee is more likely to remain rotationally unstable. Bridge-enhanced Anterior Cruciate Ligament Repair (BEAR) Implant (14) Nomura Y, Kuramochi R, Fukubayashi T. Evaluation of hamstring muscle strength and morphology after anterior cruciate ligament reconstruction. is a founder, paid consultant, and equity holder in Miach Orthopaedics, Inc, which was formed to work on upscaling production of the BEAR scaffold. Orthop J Sports Med. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. Background: 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. 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. 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. The BEAR implant goes into single graft tunnels drilled into the femur and tibia like ACLR surgery. Upper right panel: After a cortical button carrying free sutures (green) is passed up through the femoral tunnel, the BEAR implant is loaded onto them and soaked with up to 10 mL of autologous blood. Migliorini F, Vecchio G, Eschweiler J, Schneider SM, Hildebrand F, Maffulli N. J Orthop Traumatol. Purpose/hypothesis: The purpose of this study was to report the 12- and 24-month outcomes of patients who . In a statement, Martha Shadan, president and CEO of Miach Orthopaedics, said the implant represented the first substantial advancement in the treatment of ACL tears in decades. During surgery, the patients own blood is injected into the implant to form a device-protected clot that enables the body to heal. (D) The ends of the torn ACL then grow into the scaffold, which is gradually replaced by healing ligament tissue. 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. 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. Epub 2013 Aug 18. If you have questions or comments about this blog post, please email us at [emailprotected]. December 16, 2020. The .gov means its official. D.E.K., L.J.M., and Y.-M.Y. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. By clicking Accept All Cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. 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. 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. Kristen Fischer is a journalist who has covered health news for more than a decade. Li J, Rothrauff B, Chen S, Zhao S, Wu Z, Chen Q, He J. Orthop J Sports Med. NCT02664545 (ClinicalTrials.gov identifier). -, Ageberg E, Roos HP, Silbernagel KG, Thomee R, Roos EM. The Most Comprehensive Orthopedic Care in the Region, Orthopedic Surgeons and Specialists in Rhode Island, Meet Our Team - Shoulder and Elbow Specialists, As Orthopedic Patients Get Younger, Procedures Get More Advanced, Meet Our Team - Sports Medicine Specialists, Meet Our Team - Orthopedic Trauma Specialists, Research Breaks Through to the Other Side of the Blood Brain Barrier, Cerebral Palsy: Enhancing Functional Recovery, ACL Research: A Q&A with Braden Fleming, PhD, Predicting Thumb Carpometacarpal Osteoarthritis, Pursuing the Promise of Smart Joint Implants, Women's Lacrosse Focus of Lifespan Bioengineering Researcher, Surgeons Persistence, Prowess Saves Fishermans Hand, Cartilage Transplant Returns Brittney to Athletic Activity, Research and Clinical Trials at the Lifespan Orthopedics Institute, Have suffered a complete ACL tear (as documented on an MRI scan by a medical professional) within the past 50 days, Were advised by a medical professional that surgery is recommended to treat the ACL tear, Are willing to follow the study instructions for return visits and rehabilitation exercises. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. (17) Centeno CJ, Pitts J, Al-Sayegh H, Freeman MD. 2 nonabsorbable sutures (green sutures) and No. -. Given that most reinjuries following BEAR and ACL reconstruction occur within the first year, the long-term results are likely to remain excellent.. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530.
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