Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. When Does a Partial ACL Tear Require Surgery? Knee. This research was also conducted with support from the Football Players Health Study at Harvard University. The peripheral higher signal intensity (lighter gray) indicates increased higher water content in the tissues surrounding the repaired ACL. (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. 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. 2017;45(1):97105. (9) Kamien PM, Hydrick JM, Replogle WH, Go LT, Barrett GR. . BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). James Lacy, MLS, is a fact-checker and researcher. The BEAR device must be implanted within 50 days of injury. The most significant differences are that BEAR still requires surgery, and the Regenexx Perc-ACLR procedure is a precise image-guided injection. B.L.P. In Complete ACL Tears, Bridge-Enhanced ACL Repair Was Noninferior to ACL Reconstruction for Symptoms and Functioning and Knee Laxity at 2 Years. 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. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). An official website of the United States government. 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. B.C.F. The BEAR group had a significantly higher mean hamstring muscle strength index than the ACLR group at 2 years (98.2% vs 63.2%; P < .001). The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. During surgery, the patients own blood is injected into the implant to form a device-protected clot that enables the body to heal. The https:// ensures that you are connecting to the 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. The implant is resorbed by the body, usually within eight weeks. Results: 2016;44(7):16601670. 2 nonabsorbable sutures (green sutures) and No. 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.. Injury must have occurred within the last 50 days. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Media Contact:Abby Capobianco, 240-461-9059Consumer Inquiries: [emailprotected], 888-INFO-FDA. "This is very novel. Martha Murray, MD, an orthopedic surgeon at Boston Childrens Hospital and professor at Harvard Medical School who spearheaded the research, notes that the implantis made of the same proteins found in the normal ACL. (13) Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. 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. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. -, Anderson MA, Gieck JH, Perrin DH, Weltman A, Rutt RA, Denegar CR. 2023 Feb;17(1):12-21. doi: 10.1177/18632521221149059. 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. PMID: 23897997. 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. In 2020 Murray et al reported the outcome results of their Level I randomized-controlled trial examining a similar cohort of patients . ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. 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. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. The BEAR Implant was cleared by the U.S. Food & Drug Administration through the De Novo Pathway. Failure rates for anterior cruciate ligament (ACL) repair are greater than those for ACL reconstruction. Lower right panel: The sutures and extracortical buttons are secured. Knee Surg Sports Traumatol Arthrosc. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. Review article: validity of the KT-1000 knee ligament arthrometer. Am J Sports Med. An official website of the United States government. J Exp Orthop. 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. (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. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. 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. 90 clinic locations offering non-surgical Regenexx solutions for musculoskeletal pain. (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. 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. Epub 2020 Jun 25. Am J Sports Med. 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. has received educational support and hospitality payments from Kairos Surgical. and transmitted securely. (10) Song EK, Seon JK, Yim JH, Woo SH, Seo HY, Lee KB. Businesswire. 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. sharing sensitive information, make sure youre on a federal Given that most reinjuries following BEAR and ACL reconstruction occur within the first year, the long-term results are likely to remain excellent.. These preclinical studies were critical for obtaining FDA approval in 2014 for the first-in-human study (BEAR I), which was initiated February 2015. -. If the latter holds true in clinical patients, then the impact of the BEAR procedure will be even greater.. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. However, whether patients experience a faster psychological recovery after BEAR than traditional ACLR is unknown. (5) Sanborn RM, Badger GJ, Proffen B, et al. 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 . 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. 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). Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? Given the promising results of the BEAR procedure in the BEAR I and BEAR II trials, two additional studies were approved by the FDA the BEAR III trial and the BEAR-MOON trial. Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. Epub 2013 Aug 19. The primary objective of the BEAR I trial was to show that there would be no major complications (i.e., inflammation, infection, or rejection) in patients who received the implant. 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. M.M.M. Y.-M.Y. CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study. is a founder, paid consultant, and equity holder in Miach Orthopaedics, Inc, which was formed to work on upscaling production of the BEAR scaffold. 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. 2021 Apr;29(4):518-526. doi: 10.1016/j.joca.2021.01.004. Epub 2020 Apr 16. 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. Surgery can be tailored accordingly. is an assistant editor for The American Journal of Sports Medicine, the spouse of M.M.M. has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. We published the first half of a Randomized Controlled Trial last year and have completed that trial, with the full study to be published this year (15). In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. All rights reserved. This concept led to the development of the Bridge-Enhanced ACL Restoration (BEAR) Implant, a fundamental change in the approach to treating ACL injuries. We hypothesized that female sex would have significantly worse early functional outcomes and higher retear rates following primary repair of the ACL enhanced with a tissue-engineered scaffold . For those looking for a tried and tested method, and who may need to get back to activity quickly, they may want to stick with a traditional ACL repair, Getgood says. 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. These results were key to receiving FDA clearance for the BEAR implant in December of 2020. The BEAR Implant is available in select cities across the U.S. Dr. David Johannesmeyer is the first sports medicine surgeon to perform a BEAR Implant ACL Repair. Surgical techniques in the management of pediatric anterior cruciate ligament tears: Current concepts. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. 2021 Feb 3;103 (3):e14. The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction. The relationships among isometric, isotonic, and isokinetic concentric and eccentric quadriceps and hamstring force and three components of athletic performance. 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. 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. When typing in this field, a list of search results will appear and be automatically updated as you type. 2020 Feb;44(2):365-380. doi: 10.1007/s00264-019-04417-8. Epub 2023 Apr 13. This site needs JavaScript to work properly. Epub 2018 Jul 22. Dont wait. AOSSM checks author disclosures against the Open Payments Database (OPD). Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. 2013 Jun 28;15(3):205-14. doi: 10.5604/15093492.1058410. The BEAR procedure is a new and different way of thinking about the surgical approach to treating ACL injuries. Today, the U.S. Food and Drug Administration granted marketing authorizationunder the De Novo premarket review pathwayfor an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. 2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. Epub 2010 Jun 16. Migliorini F, Vecchio G, Eschweiler J, Schneider SM, Hildebrand F, Maffulli N. J Orthop Traumatol. Thus, there remains a need to find a new method that is less invasive and has the potential to provide better outcomes. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. PMID: 30176875; PMCID: PMC6122476. PMID: 30737199. FOIA Am J Sports Med. The U.S. Food and Drug Administration (FDA) approved a new implant that can repair some anterior cruciate ligament (ACL) injuries. Her discoveries led to the conceptualization of an implant that could be placed between the torn ends of the ACL to bridge the gap, which is then mixed with the patients own blood to stimulate healing. government site. 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. This allows for ACL repair. Cartilage. 2015 Jun;25(3):301-7. doi: 10.1111/sms.12205. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. U.S. Food and Drug Administration. 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. Marketing authorization allows manufacturers to bring a medicinal product to the market. For the BEAR Trial Team, B.P. 8600 Rockville Pike The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. 2021 Jun;39(6):1281-1288. doi: 10.1002/jor.24783. The .gov means its official. 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. HHS Vulnerability Disclosure, Help Patients must have an ACL stump attached to the tibia to construct the repair. NCT02664545 (ClinicalTrials.gov identifier). Patients must have an ACL stump attached to the tibia to construct the repair. In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. One hundred patients (median age, 17 years; median preoperative Marx activity score, 16) with complete midsubstance ACL injuries were enrolled and underwent surgery within 45 days of injury. 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. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. Background: (2) Culvenor AG, Eckstein F, Wirth W, Lohmander LS, Frobell R. Loss of patellofemoral cartilage thickness over 5 years following ACL injury depends on the initial treatment strategy: results from the KANON trial. Bookshelf Patients report more satisfaction in terms of pain, symptoms, and readiness. Detailed Description: 2010 Sep;26(9):1212-25. doi: 10.1016/j.arthro.2010.01.003. Read our. Posterior cruciate ligament repair seems safe with low failure rates but more high level evidence is needed: a systematic review. The BEAR III trial was designed to evaluate the effects of age on outcomes following the BEAR procedure. Patients with the implant had an average that was greater by 1.61 mm in the treated knee compared to their untreated knee. 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. 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. 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. "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. Fourth, there is no need to take a tendon graft with BEAR, so things like hamstrings and quadriceps weakness are avoided. Disclaimer. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. 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. M.M.M. Dr. Fleming: ACL reconstruction surgery in active patients has been the gold standard treatment for more than three decades. 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.
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