First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. And what does it have to do with my (ouch) torn ACL (anterior cruciate ligament)? Incidence of Second ACL Injuries 2 Years After Primary ACL Reconstruction and Return to Sport. 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. December 16, 2020. 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. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. During that time, we have observed that younger patients are ready to return to sports at four months, with older patients at six months. This new technique provides promise that soon surgeons will be able to repair and regenerate the ACL instead of replacing it. Annually in the United States, as many as 250,000 people suffer an ACL tear [2 . 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. and transmitted securely. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. eCollection 2019 Mar. 2014;42(7):1567-1573. doi:10.1177/0363546514530088. The BEAR Implant is absorbed by the body as the ACL heals. PMID: 24646218. James received a Master of Library Science degree from Dominican University. These results were key to receiving FDA clearance for the BEAR implant in December of 2020. The site is secure. 2009;17:77-79. In Complete ACL Tears, Bridge-Enhanced ACL Repair Was Noninferior to ACL Reconstruction for Symptoms and Functioning and Knee Laxity at 2 Years. 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 . Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. Fourth, there is no need to take a tendon graft with BEAR, so things like hamstrings and quadriceps weakness are avoided. More information about this clinical trial and the BEAR ACL restoration procedure is available at www.bearmoon.org. Based on what I have observed for MRI evidence of healing on the images shared by the company that makes the BEAR implant and physicians online trying this procedure, the ligament reconstitution is not complete until 12 months. PMID: 23897997. PMID: 26261424; PMCID: PMC4527573. Lower right panel: The sutures and extracortical buttons are secured. These promising results suggest that longer-term studies of this technique are justified. FDA authorizes marketing of new implant to repair a torn ACL. 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. National Library of Medicine The Football Players Health Study is funded by a grant from the National Football League (NFL) Players Association. (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. 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. 2006;34(1):128135. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. 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. Knee Surg Sports Traumatol Arthrosc. Like the ACLR surgery, the BEAR implant only focuses on repairing a single bundle, so the knee is more likely to remain rotationally unstable. Within eight weeks, the body absorbs the implant and replaces it with new tissue that gets stronger over time. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. 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. 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. 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. 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. Ive summarized the comparison above. Patients were unblinded after their 2-year visit. Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. These patients are currently being followed to determine long term outcomes. ACL injuries are among the most common knee injuries and affect around 400,000 Americans each year. Is the BEAR Implant Safe? . 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. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. "ACL reconstruction is one of the most common procedures in sports medicine," said . Lower extremity compensatory neuromuscular and biomechanical adaptations 2 to 11 years after anterior cruciate ligament reconstruction. 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.. 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]). 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. Please enable it to take advantage of the complete set of features! The U.S. Food and Drug Administration (FDA) approved a new implant that can repair some anterior cruciate ligament (ACL) injuries. 2023;9:8. doi: 10.1051/sicotj/2023007. Updated December 16, 2020. Updated April 2020. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Careers. Background: 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). (D) The ends of the torn ACL then grow into the scaffold, which is gradually replaced by healing ligament tissue. 2017;45:97-105. National Library of Medicine Other patients showed higher signal intensity within the graft itself (eg, bottom row [third from left]), reflecting increased fluid within the graft. Bethesda, MD 20894, Web Policies 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. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human; scaffold-enhanced ACL repair. 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. Background: 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. PMID: 23959965. Patients with the implant had an average that was greater by 1.61 mm in the treated knee compared to their untreated knee. 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). That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. Purpose/hypothesis: The purpose of this study was to report the 12- and 24-month outcomes of patients who . (8) Nyland J, Klein S, Caborn DN. Am J Sports Med. Failure rates for anterior cruciate ligament (ACL) repair are greater than those for ACL reconstruction. 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. 2017;45(1):97105. The BEAR Implant from Miach Orthopaedics was approved by the U.S. Food and Drug Administration in December 2020. Keywords: The homogeneous low signal intensity (black) in some patients (eg, top row [first from left] and bottom row [second from left]) is typical of the normal in situ hamstring tendon because of highly organized connective tissue with little free water. Epub 2019 Feb 8. 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. 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. Barnes DA, Badger GJ, Yen YM, Micheli LJ, Kramer DE, Fadale PD, Hulstyn MJ, Owens BD; BEAR Trial Team; Flannery SW, Ecklund K, Sanborn RM, Costa MQ, Chrostek C, Proffen BL, Sant N, Murray MM, Fleming BC, Kiapour AM. Most of these injuries happen to non-professional athletes. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knee's natural anatomy and function. Before sharing sensitive information, make sure you're on a federal government site. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. Do you have a torn ACL? sharing sensitive information, make sure youre on a federal has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. All rights reserved. Disclaimer. What is it? 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. PMID: 33549723. 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3. 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. Am J Sports Med. L.J.M. PMC Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. 2021 Feb 3;103 (3):e14. Progression of osteoarthritis after double- and single-bundle anterior cruciate ligament reconstruction. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. Why is that an issue? Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. Methods: 2 absorbable suture (purple) is placed into the tibial stump of the ACL. U.S. Food and Drug Administration. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. 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. Epub 2018 Jul 22. 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. So hopefully, well see more ACL repair than tendon grafts in the near future! 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. 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. Batista JP, Maestu R, Barbier J, Chahla J, Kunze KN. Clipboard, Search History, and several other advanced features are temporarily unavailable. Unauthorized use of these marks is strictly prohibited. The https:// ensures that you are connecting to the The BEAR procedure is a new and different way of thinking about the surgical approach to treating ACL injuries. 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. ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. J Pain Res. 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 FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. 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. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). Osteoarthritis Cartilage. Raquel Peat PhD [1]. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. (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. has equity interests in and is a consultant for MIACH Orthopaedics. PMID: 20810079. About Miach Orthopaedics, Inc. Vandenrijt J, Callenaere S, Van der Auwera D, Michielsen J, Van Dyck P, Heusdens CHW. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. Small tunnels (4 mm) are drilled in the femur and tibia, and a cortical button with two No. 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. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. 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 . 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. When typing in this field, a list of search results will appear and be automatically updated as you type. 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.". also has received multiple payments for food and beverage from various companies. Federal government websites often end in .gov or .mil. Epub 2013 Aug 19. If the repair does fail, it is much easier to fix than when a graft fails, he says. Share this article. Dr. Fleming: ACL reconstruction surgery in active patients has been the gold standard treatment for more than three decades. 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. 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 . -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. Scand J Med Sci Sports. When Does a Partial ACL Tear Require Surgery? Epub 2016 May 13. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Media Contact:Abby Capobianco, 240-461-9059Consumer Inquiries: [emailprotected], 888-INFO-FDA. Recruitment for the BEAR MOON trial was initiated in September of 2021 and the study is currently underway. The .gov means its official.Federal government websites often end in .gov or .mil. 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. Murray also believes the implant will be a new gold standard for ACL repair in the future. When applied correctly to suitable patients, these two really shouldnt compete head to head in that they are focused on two different types of ACL injuries. PMID: 23962647. Tissue Eng Part A. Quantitative MRI Biomarkers to Predict Risk of Reinjury Within 2 Years After Bridge-Enhanced ACL Restoration. 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.
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