Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive. ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. An erratum has been published: J Bone Joint Surg Am. Fleming says the FDA approval was exciting news that provides a treatment alternative to ACL reconstruction that does not require removing the injured ligament and replacing it with a graft of tendon.. Disclaimer. This site needs JavaScript to work properly. Osteoarthritis Cartilage. Within eight weeks, the body absorbs the implant and replaces it with new tissue that gets stronger over time. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. 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. All rights reserved. Epub 2019 Feb 8. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Lower left panel: The free suture ends (green) at the tibial end of the BEAR implant (which was positioned between the 2 ends of the torn ACL) are passed through the tibial tunnel to be tied over a second extracortical button. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. Determining the Need for Surgery When You Feel Better Post-ACL Tear, Treating a Torn ACL Knee in Children and Teens, Surgery Treatments for Knee Pain and Injuries, Why Knee Arthritis Is Likely to Develop After an ACL Tear, Using Your Own Tissue vs. Donor Graft for ACL Surgery, Tympanoplasty Surgery: Everything You Need to Know, Meniscus Tears: Symptoms, Diagnosis, and Treatment. J Transl Med. Patients received physical therapy and were followed for two years. In total, 96% of the patients returned for 2-year follow-up. Find a Surgeon. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. How The BEAR Implant Works To Heal ACL Tears This new technique provides promise that soon surgeons will be able to repair and regenerate the ACL instead of replacing it. Orthop J Sports Med. Harvard Health Publishing. Would you like email updates of new search results? Unauthorized use of these marks is strictly prohibited. PMID: 33549723. AR065462 and R01AR056834). HHS Vulnerability Disclosure, Help Federal government websites often end in .gov or .mil. Background: While a sex effect on outcomes following anterior cruciate ligament (ACL) reconstruction surgery has been previously documented, less is known following bridge-enhanced ACL repair (BEAR). PMID: 23962647. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. 2020 08:00 AM Eastern Standard Time. 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. In order to classify the BEAR (Bridge-Enhanced ACL Repair) Implant into class I or II, it is necessary that the also has received multiple payments for food and beverage from various companies. (6) Patterson MR, Delahunt E. A diagonal landing task to assess dynamic postural stability in ACL reconstructed females. AOSSM checks author disclosures against the Open Payments Database (OPD). That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. During surgery, the patients own blood is injected into the implant to form a device-protected clot that enables the body to heal. Epub 2016 May 13. eCollection 2022 Oct. See this image and copyright information in PMC. 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. 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 FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. 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. 2015 Jun;25(3):301-7. doi: 10.1111/sms.12205. M.M.M. One of the most important findings of her research is that performing an ACL repair is very difficult, and it explains why initial attempts in the 1970's and 1980's did not work . PMID: 23959965. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. eCollection 2023 Apr. . These patients are currently being followed to determine long term outcomes. 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. Arthroscopy. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. Outcomes-including the IKDC Subjective Score, the side-to-side difference in instrumented AP knee laxity, and muscle strength-were assessed at 2 years by an independent examiner blinded to the procedure. This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. B.L.P. ACL (anterior cruciate ligament) injuries. Epub 2016 Jul 27. Why is that an issue? "We are working hard to determine if there are specific factors that would identify patients who would be ideal candidates, Fleming says. BEAR: An Innovative Solution for an ACL Tear eCollection 2021 Nov. Barnett S, Badger GJ, Kiapour A, Yen YM, Henderson R, Freiberger C, Proffen B, Sant N, Trainor B, Fleming BC, Micheli LJ, Murray MM, Kramer DE. The FDA granted marketing authorization for an implant to repair the injury. The Bridge-Enhanced ACL Repair (BEAR) Implant is an alternative to ACL reconstruction, which typically requires harvesting tendonsand sometimes bonefrom another part of the patients body or a deceased donor. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. Environmental, Social and Governance (ESG), HVAC (Heating, Ventilation and Air-Conditioning), Machine Tools, Metalworking and Metallurgy, Aboriginal, First Nations & Native American, Office of Orthopedic Devices, Office of Product Evaluation and Quality, FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection. An official website of the United States government. FDA Authorizes Marketing of New Implant to Repair a Torn ACL 2023;9:8. doi: 10.1051/sicotj/2023007. Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. 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. Background: Preclinical studies suggest that for complete midsubstance anterior cruciate ligament (ACL) injuries, a suture repair of the ACL augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair [BEAR]) may be a viable alternative to ACL reconstruction (ACLR). 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. Murray, M, et al. 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. 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. Patients were unblinded after their 2-year visit. Conclusion: In Complete ACL Tears, Bridge-Enhanced ACL Repair Was Noninferior to ACL Reconstruction for Symptoms and Functioning and Knee Laxity at 2 Years. Many patients never regain their full level of physical activity, even after the procedure., There are a number of advantages to repairing a ligament instead of replacing it," Murray, who founded Miach Orthopaedics, which manufactures the implant, said in a statement. "That is why, more than 30 years ago, we set out to find a way to help the ligament heal itself.". 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. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Methods: The caveat about using the implant is that the technique is most effective if the ligament ruptures mid-substance, or about the middle of the ligament, to provide two ends that are able to be sutured together. Li J, Rothrauff B, Chen S, Zhao S, Wu Z, Chen Q, He J. Orthop J Sports Med. PDF Bridge-Enhanced Anterior Cruciate Ligament Repair: The Next Step 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. Before HHS Vulnerability Disclosure, Help Please enable it to take advantage of the complete set of features! Detailed Description: Injury must have occurred within the last 50 days. Knee extension and flexion muscle power after anterior cruciate ligament reconstruction with patellar tendon graft or hamstring tendons graft: a cross-sectional comparison 3 years post surgery. 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). 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. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. In theory, this is ideal, as it would be healing of native tissue to the knee and not require injuring a different portion of the body to just fix another, Lepley tells Verywell. has equity interests in and is a consultant for MIACH Orthopaedics, a company that has licensed the BEAR scaffolding technology from Boston Childrens Hospital, which is also an equity holder in MIACH Orthopaedics; has patents/patents pending for the BEAR technology from Boston Childrens Hospital and Rhode Island Hospital; has received payment for grant review from the Musculoskeletal Transplant Foundation; receives royalties from Springer; and has research grants from the NIH, the Department of Defense, and the NFL Players Association through the Football Players Health Study. 2023 Mar;51(3):NP12-NP14. This research was also conducted with support from the Football Players Health Study at Harvard University. 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. Please enable it to take advantage of the complete set of features! Dr. Fleming: ACL reconstruction surgery in active patients has been the gold standard treatment for more than three decades. One or more of the authors has declared the following potential conflict of interest or source of funding: This work was funded by the Translational Research Program at Boston Childrens Hospital, the Childrens Orthopaedic Surgery Foundation, the Childrens Sports Medicine Foundation, and the National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant Nos. Likely lowered prevalence of early arthritis and tearing the opposite ACL as the normal biomechanics of the knee are preserved. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. and transmitted securely. NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. J Orthop Sports Phys Ther. Arthrometer testing demonstrated mean side-to-side differences in AP laxity that were similar in the 2 groups at 24 months (BEAR, 1.94 2.08 mm; ACLR, 3.14 2.66 mm). J Orthop Res. Kristen Fischer is a journalist who has covered health news for more than a decade. The intact fibers have low signal intensity (black), reflecting highly organized tissue with little free water. Regenexx Perc-ACLR has been performed since 2012. BEAR-MOON? Marketing authorization allows manufacturers to bring a medicinal product to the market. Cision Distribution 888-776-0942 These results were key to receiving FDA clearance for the BEAR implant in December of 2020. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. Lower extremity compensatory neuromuscular and biomechanical adaptations 2 to 11 years after anterior cruciate ligament reconstruction. The U.S. Food and Drug Administration (FDA) approved a new implant that can repair some anterior cruciate ligament (ACL) injuries. 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. *DISCLAIMER: Like all medical procedures, Regenexx Procedures have a success and failure rate. Despite minor improvements to the procedure, clinical outcomes have not really changed. Reduced knee laxity and failure rate following anterior cruciate ligament reconstruction compared with repair for acute tears: a meta-analysis. and transmitted securely. The patient needs to have some tissue intact after the tear for the implant to work. 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. 2018;26:1362-1366. The BEAR Implant is different because it works with . Schematic of the technique used to place the BEAR implant. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. The content is solely the responsibility of the authors and does not necessarily represent the official views of Harvard Medical School, Harvard University or its affiliated academic health care centers, the NFL Players Association, Boston Childrens Hospital, or the NIH. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. Thats the Regenexx Perc-ACLR procedure (Percutaneous ACL Repair). M.M.M. How is the BEAR implant different from reconstruction? 2021 Feb 3;103 (3):e14. (From Murray et al.). Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. The problem is that the recent research from Harvard shows that drilling these graft tunnels likely means a significant second severe inflammatory hit to the cartilage (2-4). New technique for ACL repair taps body's own healing power
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