Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the body's own tissue. -, 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. 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. Ortop Traumatol Rehabil. FDA Authorizes Marketing of New Implant to Repair a Torn ACL 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. 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. In order to classify the BEAR (Bridge-Enhanced ACL Repair) Implant into class I or II, it is necessary that the Federal government websites often end in .gov or .mil. Other patients showed higher signal intensity within the graft itself (eg, bottom row [third from left]), reflecting increased fluid within the graft. These are: The acronym BEAR stands for Bridge Enhanced ACL Repair. Patients were unblinded after their 2-year visit. The U.S. Food and Drug Administration (FDA) approved a new implant that can repair some anterior cruciate ligament (ACL) injuries. 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. D.E.K. Murray MM, Kalish LA, Fleming BC; BEAR Trial Team; Flutie B, Freiberger C, Henderson RN, Perrone GS, Thurber LG, Proffen BL, Ecklund K, Kramer DE, Yen YM, Micheli LJ. 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. M.M.M. 2023 Mar;51(3):NP12-NP14. Bridge-enhanced Anterior Cruciate Ligament Repair (BEAR) Implant Researchers at MedStar Health Use the BEAR Implant to Repair ACL Tears This concept led to the development of the Bridge-Enhanced ACL Restoration (BEAR) Implant, a fundamental change in the approach to treating ACL injuries. The signal intensity within the graft is variable. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. Age, graft size, and Tegner activity level as predictors of failure in anterior cruciate ligament reconstruction with hamstring autograft. Comparable outcomes seen for bridge-enhanced ACL repair - Healio How The BEAR Implant Works To Heal ACL Tears Br J Sports Med. The https:// ensures that you are connecting to the -, 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. The ACL, a ligament located with the knee, is the tissue responsible for bridging the shinbone to the thigh bone. An official website of the United States government. Commercial Availability of BEAR Implant - Miach Orthopaedics Orthop J Sports Med. Careers. 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. The advantages are: In past decade, we have published two MRI analysis case series demonstrating good healing of the ACL with the Perc-ACLR procedure (16,17). Patients received physical therapy and were followed for two years. However, the BEAR technology has the potential to transform the way we treat ACL injuries, with restoration of the native ligament and without the need to harvest a graft from another part of the knee. . Review article: validity of the KT-1000 knee ligament arthrometer. 2023;9:8. doi: 10.1051/sicotj/2023007. Irradiated Hamstring Tendon Allograft Versus Autograft for Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction: Midterm Clinical Outcomes. 2023 Feb 20;24(1):8. doi: 10.1186/s10195-023-00688-5. J Orthop Surg (Hong Kong). 2023 Apr 26;10(1):49. doi: 10.1186/s40634-023-00605-z. On the other hand, those in the control group had a laxity in the treated knee of 1.77 mm. Knee Surg Sports Traumatol Arthrosc. Lower extremity compensatory neuromuscular and biomechanical adaptations 2 to 11 years after anterior cruciate ligament reconstruction. Epub 2013 Aug 18. PMID: 32558951. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. Background: This study assessed the safety of the newly developed bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR), which involves suture repair of the ligament combined with a bioactive scaffold to bridge the gap between the torn ligament ends. The request was submitted under section 513(f)(2) of the FD&C Act. PMID: 24646218. ACL (anterior cruciate ligament) injuries. Meaning these patients return to sports just like those who get ACLR surgery. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture. "Torn ACLs are among the most common knee injuries in the United States," according to Capt. Thank you, {{form.email}}, for signing up. AR065462 and R01AR056834). is a founder, paid consultant, and equity holder in Miach Orthopaedics, Inc, which was formed to work on upscaling production of the BEAR scaffold. The injury does not heal on its own, so ACL reconstruction is the only way to repair it. Third, while its unknown if knees repaired with BEAR retain their position sense, thats much more likely than the tendon graft placed by ACLR surgery. Despite this, the young and active population that BEAR was tested had excellent outcomes that were at least as similar as those receiving ACL reconstruction.. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. If the latter holds true in clinical patients, then the impact of the BEAR procedure will be even greater.. 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. 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. BEAR resulted in noninferior patient-reported outcomes and AP knee laxity and superior hamstring muscle strength when compared with autograft ACLR at 2-year follow-up in a young and active cohort. 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. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL repair and is the only currently- available alternative to reconstruction with allograft, autograft or suture-only repair for the treatment of ACL rupture. Magnetic resonance imaging from the 9 patients in the bridge-enhanced anterior cruciate ligament repair (BEAR) group at 24 months shows intact anterior cruciate ligament (ACL) fibers from the femoral to tibial attachment sites (arrows). ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human. 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 Repair (BEAR) Implant is promoted as an alternative to reconstructive surgery using tendons from a patient's body or a tissue bank. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. 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). 2009;17(2):162169. . Network meta-analysis of knee outcomes following anterior cruciate ligament reconstruction with various types of tendon grafts. So far, so good, Fleming reports. 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. When a patient tears the Anterior Cruciate Ligament (ACL) in the knee and physical therapy cannot return that individual to sports, ACL reconstruction surgery (ACLR) is usually the next step. The site is secure. 2014;42(5):1049-1057. doi:10.1177/0363546514526139. Fleming says it will be interesting to see if the rate of arthritis following implant insertion will be less than in patients receiving ACL reconstruction as the teams preclinical studies suggest. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. Keywords: James Lacy, MLS, is a fact-checker and researcher. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. 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. FOIA doi: 10.1177/03635465221144035. Why? Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. Study design: 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. 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. Miach Orthopaedics' Bridge-Enhanced ACL Repair (BEAR) Implant has received marketing approval for the treatment of anterior cruciate ligament tears. PDF Bridge-Enhanced Anterior Cruciate Ligament Repair: The Next Step These patients are currently being followed to determine long term outcomes. This research was also conducted with support from the Football Players Health Study at Harvard University. -, Arneja S, Leith J. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. The patients were also measured using an arthrometer, which measures the range of movement in a joint. BEAR-MOON? Purpose/hypothesis: L.J.M. PMID: 33549723. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. This new technique provides promise that soon surgeons will be able to repair and regenerate the ACL instead of replacing it. NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. Based on what I have observed for MRI evidence of healing on the images shared by the company that makes the BEAR implant and physicians online trying this procedure, the ligament reconstitution is not complete until 12 months. *DISCLAIMER: Like all medical procedures, Regenexx Procedures have a success and failure rate. So hopefully, well see more ACL repair than tendon grafts in the near future! All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. The current technique for bridge-enhanced ACL repair (BEAR) involves placing a resorbable protein-based implant containing autologous blood in the gap between the 2 torn ends of a midsubstance ACL tear in combination with suture repair of the ligament and a suture cinch to reduce the tibiofemoral joint . Epub 2014 Mar 20. Finally, returning to play is likely much quicker for a precise image-guided injection than the BEAR surgery. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. 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. How is the BEAR implant different from reconstruction? -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. The .gov means its official. In addition, 14% of the BEAR group and 6% of the ACLR group had a reinjury that required a second ipsilateral ACL surgical procedure (P = .32). Propensity for Clinically Meaningful Improvement and Surgical Failure After Anterior Cruciate Ligament Repair. Duke . Epub 2010 Jun 16. When typing in this field, a list of search results will appear and be automatically updated as you type. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. . 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. Researchers are hopeful this implant will become the new standard of care for ACL injuries. 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. The ACL implant isnt a traditional device like those used in most joint repairs. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA Authorizes Marketing of New Implant to Repair a Torn ACL, Office of Orthopedic Devices, Office of Product Evaluation and Quality. Lower right panel: The sutures and extracortical buttons are secured. Federal government websites often end in .gov or .mil. The implant is aimed at patients at least 14 years of age who have experienced a complete ACL rupture confirmed with magnetic resonance imaging (MRI) scan. In total, 96% of the patients returned for 2-year follow-up. is an assistant editor for The American Journal of Sports Medicine, the spouse of M.M.M. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human; scaffold-enhanced ACL repair. The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. At the same time point, the Regenexx Perc-ACLR procedure had an 8% surgery rate, which more similar to the 6% conversion to a second surgery after ACLR surgery reported in the BEAR study. Methods: 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. J Transl Med. On June 4, 2020, FDA received your De Novo requesting classification of the BEAR (Bridge-Enhanced ACL Repair) Implant. Bridge Enhanced ACL Restoration (BEAR Implant) 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. This site needs JavaScript to work properly. 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. PMC Careers. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. An erratum has been published: J Bone Joint Surg Am. eCollection 2016 Nov. Barnett SC, Murray MM, Badger GJ; BEAR Trial Team; Yen YM, Kramer DE, Sanborn R, Kiapour A, Proffen B, Sant N, Fleming BC, Micheli LJ. 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. 2023 Dotdash Media, Inc. All rights reserved, Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. with the inherently same conflicts. And what does it have to do with my (ouch) torn ACL (anterior cruciate ligament)? 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. J Pain Res. Third, while it's unknown if knees repaired with BEAR retain their position sense, that's much more likely than the tendon graft . 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. The patient's own blood is injected into the implant during the surgical implantation procedure with the intent of forming a device-protected clot that enables the body's healing process. BEAR: An Innovative Solution for an ACL Tear Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. A new absorbable device known as the Bridge-Enhanced ACL Repair (BEAR) was approved by the Food and Drug Administration (FDA) to repair some anterior cruciate ligament (ACL) injuries. Am J Sports Med. Am J Sports Med. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. By Kristen Fischer It is recommended that the BEAR device be implanted within 50 days of injury. The International Knee Documentation Committee subjective knee evaluation form: normative data. 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. sharing sensitive information, make sure youre on a federal Unauthorized use of these marks is strictly prohibited.
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