The BEAR-MOON trial is enrolling 200 English-speaking individuals nationwide who: Our team of board-certified orthopedic sports medicine surgeons and researchers specializes in arthroscopic repair of sports-related injuries including complex knee reconstructions. 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. NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. Reduced knee laxity and failure rate following anterior cruciate ligament reconstruction compared with repair for acute tears: a meta-analysis. 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). This provides a healing environment for the torn ACL fibers to repair themselves together, thereby eliminating the need to harvest any tissue for a graft. Vandenrijt J, Callenaere S, Van der Auwera D, Michielsen J, Van Dyck P, Heusdens CHW. PMID: 23962647. 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. Am J Sports Med. 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. Lower extremity compensatory neuromuscular and biomechanical adaptations 2 to 11 years after anterior cruciate ligament reconstruction. 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 FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. 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. Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . "Torn ACLs are among the most common knee injuries in the United States," according to Capt. Tissue Eng Part A. 2 nonabsorbable sutures (green sutures) and No. Epub 2023 Jan 16. This is a bovine collagen implant inserted in the torn area of the ACL with sutures placed in graft tunnels. See this image and copyright information in PMC. The ACL implant isnt a traditional device like those used in most joint repairs. Epub 2020 Apr 16. ACL tears are often treated with surgery called ACL reconstruction. 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. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. Epub 2020 Jun 29. Am J Sports Med. M.M.M. The site is secure. 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. Two years after surgery, the outcomes of the two procedures proved to be similar in young and active patients, though the BEAR patients had better hamstring muscle strength. This allows for ACL repair. Surgery can be tailored accordingly. The BEAR Implant is a resorbable implantmeaning it is absorbed by the bodymade from bovine collagen and is secured via suture to bridge the gap between the torn ends of a patient's ACL. Lifespan, Rhode Island's first health system, was founded in 1994 by Rhode Island Hospital and the Miriam Hospital. (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. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. and food, beverage, and travell reimbursements from 5 companies (each <$500). Verywell Health's content is for informational and educational purposes only. Preserve and heal the . Am J Sports Med. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. 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.". 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. 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). 2017;45:97-105. Key Takeaways. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. 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. 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. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. 2023;9:8. doi: 10.1051/sicotj/2023007. 2015 Jun;25(3):301-7. doi: 10.1111/sms.12205. PMID: 30176875; PMCID: PMC6122476. Progression of osteoarthritis after double- and single-bundle anterior cruciate ligament reconstruction. Am J Sports Med. eCollection 2019 Mar. Schematic of the technique used to place the BEAR implant. Its an absorbable implant thats derived from bovine collagena naturally occurring protein present in the connective tissue. This new technique provides promise that soon surgeons will be able to repair and regenerate the ACL instead of replacing it. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Additional stitching holds the device in place. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. Kristen Fischer is a journalist who has covered health news for more than a decade. Patients must have an ACL stump attached to the tibia to construct the repair. 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. During that time, we have observed that younger patients are ready to return to sports at four months, with older patients at six months. Unauthorized use of these marks is strictly prohibited. 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. 2023 Mar 2;12(5):1999. doi: 10.3390/jcm12051999. National Library of Medicine 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. The International Knee Documentation Committee subjective knee evaluation form: normative data. 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). 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. Patients must have an ACL stump attached to the tibia to construct the repair. In 2020 Murray et al reported the outcome results of their Level I randomized-controlled trial examining a similar cohort of patients . 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. Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. Am J Sports Med. Share this article. -, 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. Would you like email updates of new search results? These initial studies demonstrated that even the first surgeries performed for this technique had similar outcomes to the current gold standard of ACL reconstruction with autograft tendon, and patients did not have to have a graft harvested from their leg, she says. Rhode Island Hospital is one of six U.S. hospitals conducting the BEAR-MOON trial that compares outcomes of patients receiving the BEAR implant to those receiving ACL reconstruction. 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. Background: 2021 Apr;29(4):518-526. doi: 10.1016/j.joca.2021.01.004. Br J Sports Med. In order to classify the BEAR (Bridge-Enhanced ACL Repair) Implant into class I or II, it is necessary that the M.M.M. SILVER SPRING, Md., Dec. 16, 2020 /PRNewswire/ --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. Updated December 16, 2020. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Media Contact:Abby Capobianco, 240-461-9059Consumer Inquiries: [emailprotected], 888-INFO-FDA. 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. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. Am J Sports Med. 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. Purpose/hypothesis: The purpose of this study was to report the 12- and 24-month outcomes of patients who . Orthop J Sports Med. The BEAR Implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (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. 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.. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. At the two-year mark, patients who received the BEAR Implant reported an average score of 88.6 and control subjects reported an average score of 84.6 using the International Knee Documentation Committee Subjective Score, a patient-reported outcome measure (questionnaire) that asks questions about symptoms related to pain and stiffness, sports activity and knee function. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. 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. 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. eCollection 2023 Apr. 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. -, Akelman MR, Fadale PD, Hulstyn MJ, et al. An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months; no patients in either group had C (abnormal) or D (severely abnormal) grades. Schedule an appointment with a BEAR-MOON trial physician and find out if you qualify for the trial. Schematic of the technique used to place the BEAR implant. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. Epub 2020 Jun 25. Trends in Anterior Cruciate Ligament Repair: A Bibliometric and Visualized Analysis. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. Updated April 2020. What if you could skip the surgery and instead have your Bone Marrow Concentrate (BMC), which contains healing stem cells, injected into your ACL? -, Anderson MA, Gieck JH, Perrin DH, Weltman A, Rutt RA, Denegar CR. Orthop J Sports Med. 2009;17:77-79. This difference in injury risk is an important focus of research and has been attributed to anatomy, hormonal effects, neuromuscular control, biomechanics, and sport participation. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. A comprehensive, integrated, academic health system with The Warren Alpert Medical School of Brown University, Lifespan's present partners also include Rhode Island Hospital's pediatric division, Hasbro Children's Hospital; Bradley Hospital; Newport Hospital; Gateway Healthcare; Lifespan Physician Group; and Coastal Medical. J Transl Med. The BEAR Implant is different because it works with . How is BEAR different than ACLR surgery? FDA authorizes marketing of new implant to repair a torn ACL. Clipboard, Search History, and several other advanced features are temporarily unavailable. (13) Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. (5) Sanborn RM, Badger GJ, Proffen B, et al. This concept led to the development of the Bridge-Enhanced ACL Restoration (BEAR) Implant, a fundamental change in the approach to treating ACL injuries. Do you have a torn ACL? Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Health's Office of Orthopedic Devices. That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. The patients were also measured using an arthrometer, which measures the range of movement in a joint. 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). 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 At that time, those with the implant reported on their outcomes using the International Knee Documentation Committee Subjective Score, a knee-specific patient-reported outcome measure. 2021 Jun;39(6):1281-1288. doi: 10.1002/jor.24783. 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. Read our. 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. In Complete ACL Tears, Bridge-Enhanced ACL Repair Was Noninferior to ACL Reconstruction for Symptoms and Functioning and Knee Laxity at 2 Years. However, now a new surgical implant called BEAR is shaking up that world by offering a solution to try to regrow the torn ACL.
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