2023;9:8. doi: 10.1051/sicotj/2023007. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. -, Anderson MA, Gieck JH, Perrin DH, Weltman A, Rutt RA, Denegar CR. PMID: 24646218. Bookshelf Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. In order to classify the BEAR (Bridge-Enhanced ACL Repair) Implant into class I or II, it is necessary that the On June 4, 2020, FDA received your De Novo requesting classification of the BEAR (Bridge-Enhanced ACL Repair) Implant. (11) Barenius B, Ponzer S, Shalabi A, Bujak R, Norln L, Eriksson K. Increased risk of osteoarthritis after anterior cruciate ligament reconstruction: a 14-year follow-up study of a randomized controlled trial. National Library of Medicine The intact fibers have low signal intensity (black), reflecting highly organized tissue with little free water. Home Blog The BEAR Implant for ACL Tears. Kristen Fischer is a journalist who has covered health news for more than a decade. ACL injuries are among the most common knee injuries and affect around 400,000 Americans each year. Patients received physical therapy and were followed for two years. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. Fourth, there is no need to take a tendon graft with BEAR, so things like hamstrings and quadriceps weakness are avoided. During surgery, the patients own blood is injected into the implant to form a device-protected clot that enables the body to heal. Accessibility maintained a conflict-of-interest management plan that was approved by Boston Childrens Hospital and Harvard Medical School during the conduct of the trial, with oversight by both conflict-of-interest committees and the institutional review board of Boston Childrens Hospital, as well as the US Food and Drug Administration. There are four primary goals to ACL repair using the BEAR Implant: Provide a stable knee. Lets look at the positives and negatives of this new technology and compare it to the Regenexx perc-ACLR procedure. "ACL reconstruction is one of the most common procedures in sports medicine," said . AOSSM checks author disclosures against the Open Payments Database (OPD). 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). . Orthopaedic Journal of Sports Medicine. (13) Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. B.C.F. from 8 AM - 9 PM ET. 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. Epub 2014 Mar 20. That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. However, whether patients experience a faster psychological recovery after BEAR than traditional ACLR is unknown. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. Lower extremity compensatory neuromuscular and biomechanical adaptations 2 to 11 years after anterior cruciate ligament reconstruction. The BEAR Implant is absorbed by the body as the ACL heals. Patients must have an ACL stump attached to the tibia to construct the repair. Orthop J Sports Med. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. Read our. Using the BEAR implant, no other structures in the body need to be compromised in order to harvest a graft to replace the injured ligament. 2013 Jun 28;15(3):205-14. doi: 10.5604/15093492.1058410. Conclusion: AR065462 and R01AR056834). 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. February 2022. doi:10.1177/23259671211070542. Its a multi-center, randomized, clinical trial seeking adult participants with a torn ACL that has occurred within the past 50 days, who qualify for surgery. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. Epub 2020 Apr 16. Patients must have an ACL stump attached to the tibia to construct the repair. (B) The scaffold is then saturated with 5 to 10 mL of the patients blood, and (C) the tibial stump is pulled up into the saturated scaffold. D.E.K., L.J.M., and Y.-M.Y. 2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. BEAR represents a move toward a less invasive and equally effective surgical treatment for patients with ACL injuries.. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. (16) Centeno C, Markle J, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. When I first heard about the BEAR ACL implant, I believed that the surgeon would place it in the correct spot and perhaps tack it down, meaning a far less invasive procedure than drilling graft tunnels. 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). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. It doesnt require a second wound site to remove healthy tendon and does not involve donors. 2020 08:00 AM Eastern Standard Time. BEAR ACL Repair Technique | Knee Surgeon | Minnesota PMID: 23897997. 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. 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. Like the ACLR surgery, the BEAR implant only focuses on repairing a single bundle, so the knee is more likely to remain rotationally unstable. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. Why is that an issue? Purpose/hypothesis: FDA Approves New Implant for ACL Tears - Verywell Health ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. J Transl Med. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. Am J Sports Med. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. The BEAR procedure is a new and different way of thinking about the surgical approach to treating ACL injuries. What if the anterior cruciate ligament (ACL) had the ability to repair itself? Find a Surgeon. 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. 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. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. 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. effective surgery for ACL tears.17,23 The BEAR technique does not require the compromise of other healthy tissues around the knee, as is required with ACL reconstruction with an autograft. If those that undergo the BEAR procedure return to sports faster and have lower rates of re-injury and osteoarthritis, it is definitely possible that it could become the new gold standard.. Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. ACL (anterior cruciate ligament) injuries. The BEAR device must be implanted within 50 days of injury. About Miach Orthopaedics, Inc. Noninferiority criteria were met for both the IKDC Subjective Score (BEAR, 88.9 points; ACLR, 84.8 points; mean difference, 4.1 points [95% CI, -1.5 to 9.7]) and the side-to-side difference in AP knee laxity (BEAR, 1.61 mm; ACLR, 1.77 mm; mean difference, -0.15 mm [95% CI, -1.48 to 1.17]). Epub 2020 Jun 29. Purpose/hypothesis: The purpose of this study was to report the 12- and 24-month outcomes of patients who . 2018;26:1362-1366. Y.-M.Y. Today, the U.S. Food and Drug Administration granted marketing authorizationunder the De Novo premarket review pathwayfor an anterior cruciate ligament (ACL) implant . Knee Surg Sports Traumatol Arthrosc. The BEAR implant is then injected with autologous whole blood. 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. Am J Sports Med. B.L.P. The BEAR Implant for ACL Tears - Regenexx Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH The Lifespan Orthopedics Institute is managing the only New England . FOIA The surgery, however, is not without its problems. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. Within eight weeks, the body absorbs the implant and replaces it with new tissue that gets stronger over time. 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. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. The patient needs to have some tissue intact after the tear for the implant to work. Marketing authorization allows manufacturers to bring a medicinal product to the market. This research was also conducted with support from the Football Players Health Study at Harvard University. 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 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. The Regenexx perc-ACLR procedure should be applied in patients that have a complete ACL tear, but the two ends are still connected. Hence, you would need a Regenexx network physician to look at your actual MRI images. PMID: 30737199. Small tunnels (4 mm) are drilled in the femur and tibia, and a cortical button with two No. More information about this clinical trial and the BEAR ACL restoration procedure is available at www.bearmoon.org. Surgical techniques in the management of pediatric anterior cruciate ligament tears: Current concepts. How is the BEAR implant different from reconstruction? (1) Murray MM, Fleming BC, Badger GJ; BEAR Trial Team, Freiberger C, Henderson R, Barnett S, Kiapour A, Ecklund K, Proffen B, Sant N, Kramer DE, Micheli LJ, Yen YM. 8600 Rockville Pike 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. A small percentage of patients treated with the BEAR Implant re-tore their ACL when they returned to sports sooner than recommended and then had a standard ACL reconstruction. 90 clinic locations offering non-surgical Regenexx solutions for musculoskeletal pain. doi: 10.1177/03635465221144035. 2006;34(1):128135. Dont wait. 2009;17(2):162169. "Torn ACLs are among the most common knee injuries in the United States," according to Capt. 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. ________________________________________________________________. Would you like email updates of new search results? Epub 2023 Apr 13. (7) Bczkowicz D, Skomudek A. 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. 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. Ive summarized the comparison above. -, Arneja S, Leith J. 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. 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). 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 BEAR Implant was cleared by the U.S. Food & Drug Administration through the De Novo Pathway. 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.. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. By Kristen Fischer The results were excellent (more on those below). 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. Am J Sports Med. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. eCollection 2019 Mar. FDA authorizes marketing of new implant to repair a torn ACL. 2017;45:97-105. 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. Comparable Instrumented Knee Joint Laxity and Patient-Reported Outcomes After ACL Repair: Response. 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. The BEAR procedure is a promising technique that will likely meet these goals. 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). In the BEAR procedure, the torn ACL fibers are instead sutured and stitched within the center of the knee with a device that absorbs the patients own blood and bridges the gap between the torn ends. Am J Sports Med. 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. Epub 2018 Jul 22. 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. Network meta-analysis of knee outcomes following anterior cruciate ligament reconstruction with various types of tendon grafts. Am J Sports Med. Batista JP, Maestu R, Barbier J, Chahla J, Kunze KN. Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State. Vandenrijt J, Callenaere S, Van der Auwera D, Michielsen J, Van Dyck P, Heusdens CHW. Whether it replaces ACL reconstruction as the gold standard remains to be seen but I am optimistic it will, Fleming adds. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you. 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. 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. all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. Schedule an appointment with a BEAR-MOON trial physician and find out if you qualify for the trial. (3) Hunt ER, Jacobs CA, Conley CE, Ireland ML, Johnson DL, Lattermann C. Anterior cruciate ligament reconstruction reinitiates an inflammatory and chondrodegenerative process in the knee joint. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). 2021 Feb 3;103 (3):e14. 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. Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. This site needs JavaScript to work properly. This less invasive procedure lends itself to faster recovery of muscle strength after surgery and prevents morbidities associated with traditional grafts, such as kneeling pain or hamstring deficits. 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. 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. also has received multiple payments for food and beverage from various companies. 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. NCT02664545 (ClinicalTrials.gov identifier). New technique for ACL repair taps body's own healing power FOIA When typing in this field, a list of search results will appear and be automatically updated as you type. 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. -, 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. This concept led to the development of the Bridge-Enhanced ACL Restoration (BEAR) Implant, a fundamental change in the approach to treating ACL injuries. 2010 Sep;26(9):1212-25. doi: 10.1016/j.arthro.2010.01.003. HHS Vulnerability Disclosure, Help These preclinical studies were critical for obtaining FDA approval in 2014 for the first-in-human study (BEAR I), which was initiated February 2015. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knee's natural anatomy and function. As the intra-articular environment is complex in its response to implanted materials, this study was designed to determine whether there . 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). 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.". Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. 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. Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. government site. 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. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. Knee Surg Sports Traumatol Arthrosc. Historically, the repair method of just suturing the two ends together has not been very effective.". Updated April 2020. And as it stands, implant recipients shouldnt return to a sport for nine months after their surgery, which is similar to traditional ACL reconstruction, Fleming says. It's a multi-center, randomized, clinical trial seeking adult participants with a torn ACL that has occurred within the past 50 days, who qualify for surgery . NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. Murray, M, et al. James received a Master of Library Science degree from Dominican University. Epub 2020 Apr 16. PMID: 23959965. Stepwise demonstration of the bridge-enhanced, Stepwise demonstration of the bridge-enhanced anterior cruciate ligament repair (BEAR) technique using the, Magnetic resonance imaging from the 9 patients in the bridge-enhanced anterior cruciate ligament, Magnetic resonance imaging from the 7 patients in the anterior cruciate ligament reconstruction, MeSH Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. Upper left panel: A suture (purple) is placed through the tibial stump via a whipstitch and secured with 2 free sutures (green) to an extracortical button. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. Unauthorized use of these marks is strictly prohibited. BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. The site is secure. 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. Federal government websites often end in .gov or .mil. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). (4) King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. "This is very novel. Ortop Traumatol Rehabil. Businesswire. Bridge-Enhanced ACL Repair vs ACL Reconstruction -, Akelman MR, Fadale PD, Hulstyn MJ, et al. Registration: Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. Results: Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. Only a single bundle repair of a double bundle ligament means the knee is left rotationally less stable (10), The graft tendon goes in at a steeper angle than the original ACL; hence its more likely to shear and fail (9), No working position sensors in the tendon repair of a ligament mean less position sense (6-8), High likelihood of developing arthritis/doesnt prevent arthritis (11,12), Higher chance of tearing the ACL on the other knee (13), The hamstrings or quadriceps muscles become weaker due to the graft harvest (14), A much less invasive procedure than surgery. Yang XG, Wang F, He X, Feng JT, Hu YC, Zhang H, Yang L, Hua K. Int Orthop. Results: HHS Vulnerability Disclosure, Help 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. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. The bodys own tissue eventually replaces the implant. (10) Song EK, Seon JK, Yim JH, Woo SH, Seo HY, Lee KB. Epub 2010 Jun 16. 'Breakthrough' treatment for ACL tears allows tendon to heal - WTOP Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001). 2020 Feb;44(2):365-380. doi: 10.1007/s00264-019-04417-8. Published Dec. 17, 2020 Greg Slabodkin Senior Editor Courtesy of Miach Orthopaedics Dive Brief: FDA has authorized a resorbable implant under the De Novo premarket review pathway that fills the gap between the torn ends of a patient's anterior cruciate ligament (ACL), one of the most common knee injuries in the U.S. Epub 2023 Apr 13. The study will continue to monitor knee stability and outcomes for 10 years following the procedure, with 9 post-operative visits taking place throughout the duration of . 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. Anterior Cruciate Ligament Repair: The Current Status : JBJS - LWW 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. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. 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).
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