FOIA 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 . 33,34 The scaffold is used to bridge the . Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. The American Journal of Sports Medicine. It can also be done via sutures, a medical device used to hold body tissues together. Miach Orthopaedics Inc., a privately held company dedicated to developing bio-engineered surgical implants for connective tissue repair, today announced that the U.S. Food & Drug Administration has granted the company's De Novo Request for the Bridge-Enhanced ACL Repair (BEAR) Implant, resulting in marketing approval for the treatment of anterior cruciate ligament (ACL) tears, one of the . Further work is planned Study design: The BEAR Implant was cleared by the U.S. Food & Drug Administration through the De Novo Pathway. Epub 2013 Aug 19. The https:// ensures that you are connecting to the ACL tears are often treated with surgery called ACL reconstruction. Patients who had a bridge-enhanced ACL repair technique showed similar patient-report outcomes with no infection or rejection compared with patients who had autograft ACL reconstruction, according . For full product and risk information . The recent trial results showed that 14% of patients required ACLR surgery despite the BEAR surgery (1). The BEAR III trial was designed to evaluate the effects of age on outcomes following the BEAR procedure. -. Comparable Instrumented Knee Joint Laxity and Patient-Reported Outcomes After ACL Repair: Response. The ACL implant isnt a traditional device like those used in most joint repairs. 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. 2009;17:77-79. In total, 96% of the patients returned for 2-year follow-up. 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. 2023 Mar 2;12(5):1999. doi: 10.3390/jcm12051999. Kristen Fischer is a journalist who has covered health news for more than a decade. 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. This double-bundle design ensures that the ACL can control the rotation of the tibia, an essential function in protecting the knee. 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]). Hence, you would need a Regenexx network physician to look at your actual MRI images. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. (12) Wirth W, Eckstein F, Culvenor AG, Hudelmaier MI, Stefan Lohmander L, Frobell RB. Anterior Cruciate Ligament Repair: The Current Status : JBJS - LWW Find a Surgeon. PMID: 23897997. Third, while it's unknown if knees repaired with BEAR retain their position sense, that's much more likely than the tendon graft . Repair versus reconstruction for proximal anterior cruciate ligament HHS Vulnerability Disclosure, Help 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. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR - PubMed and transmitted securely. In this procedure, the torn ACL fibers are completely removed and replaced with the graft, which is inserted arthroscopically into large tunnels drilled into the knee. 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. Bridge-Enhanced ACL Repair (BEAR) Allows Torn ACL to Heal Itself 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 Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. When the trial showed that no major complications occurred, the FDA granted approval for a second study (BEAR II) comparing outcomes of patients receiving BEAR to those receiving ACL reconstruction graft (the gold standard). Clipboard, Search History, and several other advanced features are temporarily unavailable. An official website of the United States government. 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. Epub 2020 Apr 16. During surgery, the patients own blood is injected into the implant to form a device-protected clot that enables the body to heal. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Tissue Eng Part A. BEAR: An Innovative Solution for an ACL Tear 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. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). The most significant differences are that BEAR still requires surgery, and the Regenexx Perc-ACLR procedure is a precise image-guided injection. (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. Am J Sports Med. J Pain Res. Am J Sports Med. The patient needs to have some tissue intact after the tear for the implant to work. 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. The BEAR Implant for ACL Tears - Regenexx 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. PDF Bridge-Enhanced Anterior Cruciate Ligament Repair: The Next Step See this image and copyright information in PMC. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. 2023;9:8. doi: 10.1051/sicotj/2023007. The BEAR implant is then injected with autologous whole blood. The results were excellent (more on those below). Orthop J Sports Med. Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. Dr. Hulstyn: Female athletes are at 2-8 times greater risk of primary ACL injury compared with males, even when controlling for sport and competition level. Propensity for Clinically Meaningful Improvement and Surgical Failure After Anterior Cruciate Ligament Repair. That tendon is secured in the tunnels and now serves as a replacement ligament. How is BEAR different than ACLR surgery? ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. Epub 2023 Jan 13. Migliorini F, Vecchio G, Eschweiler J, Schneider SM, Hildebrand F, Maffulli N. J Orthop Traumatol. Ortop Traumatol Rehabil. She said it had the potential to change the standard of care.. Copyright Regenexx 2023. sharing sensitive information, make sure youre on a federal 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). James received a Master of Library Science degree from Dominican University. Bio Ortho J Vol 3(1):e29e39; October 5, 2021. 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. Epub 2021 Feb 4. 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. Schedule an appointment with a BEAR-MOON trial physician and find out if you qualify for the trial. Arthrometry measures the difference in laxity between a person's healthy leg and their injured leg. Detailed Description: 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. Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. 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). 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. Knee. Likely lowered prevalence of early arthritis and tearing the opposite ACL as the normal biomechanics of the knee are preserved. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Media Contact:Abby Capobianco, 240-461-9059Consumer Inquiries: [emailprotected], 888-INFO-FDA. 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. 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. Epub 2019 Feb 8. Ive summarized the comparison above. This is a bovine collagen implant inserted in the torn area of the ACL with sutures placed in graft tunnels. Marketing authorization allows manufacturers to bring a medicinal product to the market. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. Kristen Fischer is a journalist who has covered health news for more than a decade. The typical treatment for this injury is reconstructive surgery. "This is very novel. 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. Epub 2020 Jun 25. 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. Trends in Anterior Cruciate Ligament Repair: A Bibliometric and Visualized Analysis. 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 FDAs 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. Epub 2019 Dec 19. 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. How The BEAR Implant Works To Heal ACL Tears And what does it have to do with my (ouch) torn ACL (anterior cruciate ligament)? 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. The request was submitted under section 513(f)(2) of the FD&C Act. 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. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. 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.". Patients must have an ACL stump attached to the tibia to construct the repair. Orthop J Sports Med. In a randomized controlled trial of 100 people who experienced complete ACL rupture, 65 received the implant and 35 members in a control group had reconstruction via autograft, using tendon from their own bodies. Every patient underwent physical therapy after surgery, and the team followed them for two years. The BEAR implant goes into single graft tunnels drilled into the femur and tibia like ACLR surgery. Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH FOIA -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. Cartilage. 2020 08:00 AM Eastern Standard Time. 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. What if the anterior cruciate ligament (ACL) had the ability to repair itself? How is the BEAR implant different from reconstruction? Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year - PubMed The patients own blood is injected into the implant during the surgical implantation procedure with the intent of forming a device-protected clot that enables the bodys healing process. How can you tell which type of complete ACL tear is which? Cohort study; Level of evidence, 2. However, now a new surgical implant called BEAR is shaking up that world by offering a solution to try to regrow the torn ACL. The https:// ensures that you are connecting to the Bridge Enhanced ACL Restoration (BEAR Implant) 2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. 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. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. It is a . 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. HHS Vulnerability Disclosure, Help Miach Orthopaedics' Bridge-Enhanced ACL Repair (BEAR) Implant has received marketing approval for the treatment of anterior cruciate ligament tears. Patients were unblinded after their 2-year visit. 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. 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. Epub 2013 Aug 18. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Healths Office of Orthopedic Devices, Todays marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.. By Kristen Fischer On the other hand, those in the control group had a laxity in the treated knee of 1.77 mm. Injury must have occurred within the last 50 days. It doesnt require a second wound site to remove healthy tendon and does not involve donors. Its an absorbable implant thats derived from bovine collagena naturally occurring protein present in the connective tissue. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. 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 preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. New technique for ACL repair taps body's own healing power 2017;45:97-105. Updated December 17, 2020. (8) Nyland J, Klein S, Caborn DN. 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. Yang XG, Wang F, He X, Feng JT, Hu YC, Zhang H, Yang L, Hua K. Int Orthop. Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. Epub 2023 Jan 16. Other patients showed higher signal intensity within the graft itself (eg, bottom row [third from left]), reflecting increased fluid within the graft. 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. 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. The peripheral higher signal intensity (lighter gray) indicates increased higher water content in the tissues surrounding the repaired ACL. Hence, any implant procedure requiring tunnels to be drilled will likely harm cartilage. This change to our approach will greatly benefit our patients. Annually in the United States, as many as 250,000 people suffer an ACL tear [2 . The relationships among isometric, isotonic, and isokinetic concentric and eccentric quadriceps and hamstring force and three components of athletic performance. Progression of osteoarthritis after double- and single-bundle anterior cruciate ligament reconstruction. Patients must have an ACL stump attached to the tibia to construct the repair. The data supporting the implant is very encouraging. 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 . 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. Epub 2023 Apr 13. Am J Sports Med. 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. The .gov means its official.Federal government websites often end in .gov or .mil. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. Hypothesis: 2014;42(5):1049-1057. doi:10.1177/0363546514526139. PMID: 32558951. Epub 2020 Apr 16. The purpose of this study was to report the 12- and 24-month outcomes of patients who underwent the BEAR procedure compared with a nonrandomized concurrent control group who underwent ACL reconstruction (ACLR) with an autograft. M.M.M. Conclusion: 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. Methods: (6) Patterson MR, Delahunt E. A diagonal landing task to assess dynamic postural stability in ACL reconstructed females. Epub 2016 May 13. (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. Background: More information about this clinical trial and the BEAR ACL restoration procedure is available at www.bearmoon.org. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. The bodys own tissue eventually replaces the implant. 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. The BEAR procedure is a promising technique that will likely meet these goals. (14) Nomura Y, Kuramochi R, Fukubayashi T. Evaluation of hamstring muscle strength and morphology after anterior cruciate ligament reconstruction. However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. 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. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. 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. 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. The U.S. Food and Drug Administration (FDA) approved a new implant that can repair some anterior cruciate ligament (ACL) injuries. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. 2020 Feb;44(2):365-380. doi: 10.1007/s00264-019-04417-8. (17) Centeno CJ, Pitts J, Al-Sayegh H, Freeman MD. Reduced knee laxity and failure rate following anterior cruciate ligament reconstruction compared with repair for acute tears: a meta-analysis. 2021 Apr;29(4):518-526. doi: 10.1016/j.joca.2021.01.004. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. "Today's marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.". Patients must have an ACL stump attached to the tibia to construct the repair. ________________________________________________________________. Am J Sports Med. Accessibility Why? NFL player-backed implant to fix ACL tears gets FDA De Novo This site needs JavaScript to work properly. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. These preclinical studies were critical for obtaining FDA approval in 2014 for the first-in-human study (BEAR I), which was initiated February 2015. (7) Bczkowicz D, Skomudek A. Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. 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 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). 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). Patients with the implant had an average that was greater by 1.61 mm in the treated knee compared to their untreated knee. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. 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. 2018;26:1362-1366. 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.