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. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. Annually in the United States, as many as 250,000 people suffer an ACL tear [2 . (9) Kamien PM, Hydrick JM, Replogle WH, Go LT, Barrett GR. 2023 Feb;17(1):12-21. doi: 10.1177/18632521221149059. Benefits of BEAR ACL Repair in Pediatric Patients. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. Epub 2013 Aug 19. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. At two years, control subjects had a laxity that, on average, was greater by 1.8 mm in the treated knee than that of the untreated knee. Assuming that orthopedic surgeons apply BEAR to the correct patients, these two procedures should never really compete head to head. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. Historically, the repair method of just suturing the two ends together has not been very effective.". -, Akelman MR, Fadale PD, Hulstyn MJ, et al. Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH official website and that any information you provide is encrypted A patient may recover strength faster after a BEAR than traditional ACLR. 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). The BEAR implant goes into single graft tunnels drilled into the femur and tibia like ACLR surgery. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. 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. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. Ive summarized the comparison above. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. PMID: 30176875; PMCID: PMC6122476. Kristen Fischer is a journalist who has covered health news for more than a decade. PMID: 23813800. More information about this clinical trial and the BEAR ACL restoration procedure is available at www.bearmoon.org. The Lifespan Orthopedics Institute is managing the only New England . 8600 Rockville Pike 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. Epub 2016 Jul 27. A total of 74 patients with acute proximal isolated ACL tears will be assigned in a 1:1 allocation ratio to either (I) ACL repair using cortical button fixation and additional suture augmentation or (II) ACL reconstruction using an all-inside autologous hamstring graft technique. In Complete ACL Tears, Bridge-Enhanced ACL Repair Was Noninferior to ACL Reconstruction for Symptoms and Functioning and Knee Laxity at 2 Years. Marketing authorization allows manufacturers to bring a medicinal product to the market. That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. 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. 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). The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. Harvard Health Publishing. The patients were also measured using an arthrometer, which measures the range of movement in a joint. Knee. 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. Patients received physical therapy and were followed for two years. Epub 2023 Jan 13. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. Epub 2019 Feb 8. Am J Sports Med. Cohort study; Level of evidence, 2. An official website of the United States government. The .gov means its official.Federal government websites often end in .gov or .mil. This research was also conducted with support from the Football Players Health Study at Harvard University. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. 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. D.E.K. 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). 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 . Before April 16, 2020. doi:10.1177/0363546520913532. 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. The U.S. Food and Drug Administration (FDA) approved a new implant that can repair some anterior cruciate ligament (ACL) injuries. has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. 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. eCollection 2022 Oct. See this image and copyright information in PMC. 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. Adam S. Lepley, PhD, co-director of the Michigan Performance Research Laboratory at the University of Michigan, who specializes in rehabilitation, noted that traditional ACL reconstruction focuses on rebuilding the ligament while the implant centers on repairing it. U.S. Food and Drug Administration. Patients must have an ACL stump attached to the tibia to construct the repair. TheLifespan Orthopedics Institute is managing the only New England site, one of six across the nation, to conduct the trial with our partner physicians at University Orthopedics. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the bodys own tissue. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Epub 2018 Jul 22. This concept led to the development of the Bridge-Enhanced ACL Restoration (BEAR) Implant, a fundamental change in the approach to treating ACL injuries. Am J Sports Med. 2023 Feb 20;24(1):8. doi: 10.1186/s10195-023-00688-5. 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. Murray, M, et al. However, given that BEAR is a new technology, most surgeons are unlikely to allow a return to sports at six months. The https:// ensures that you are connecting to the Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. Am J Sports Med. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. Results: In order to classify the BEAR (Bridge-Enhanced ACL Repair) Implant into class I or II, it is necessary that the 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. 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. Would you like email updates of new search results? The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. AR065462 and R01AR056834). 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. Incidence of Second ACL Injuries 2 Years After Primary ACL Reconstruction and Return to Sport. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Bio Ortho J Vol 3(1):e29e39; October 5, 2021. eCollection 2023 Apr. Study design: The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL . National Library of Medicine It is recommended that the BEAR device be implanted within 50 days of injury. 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. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. 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. A whipstitch of No. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Magnetic resonance imaging from the 7 patients in the anterior cruciate ligament reconstruction (ACLR) group at 24 months shows an intact graft between the femoral and tibial tunnels (arrows). To learn more about the BEAR-MOON trial or to schedule an appointment with a trial physician, email bear.trial@lifespan.org or call 1-401-649-1906. James Lacy, MLS, is a fact-checker and researcher. 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 . AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. Likely lowered prevalence of early arthritis and tearing the opposite ACL as the normal biomechanics of the knee are preserved. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. NCT02664545 (ClinicalTrials.gov identifier). The injury does not heal on its own, so ACL reconstruction is the only way to repair it. Perhaps the single biggest question from an athlete is, When can I return to play? For ACL surgery, the current recommendations are 1-2 years. 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. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human. 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.. Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. 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 patients ACL. 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. Epub 2016 May 13. These results were key to receiving FDA clearance for the BEAR implant in December of 2020. (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. 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. 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). Commonly, they occur in a non-contact fashion with an acute twisting of the knee. 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. . The BEAR implant is then injected with autologous whole blood. Age, graft size, and Tegner activity level as predictors of failure in anterior cruciate ligament reconstruction with hamstring autograft. Early anterior cruciate ligament reconstruction does not affect 5 year change in knee cartilage thickness: secondary analysis of a randomized clinical trial. 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 . 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. Cartilage. Updated December 16, 2020. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. 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). 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). There are four primary goals to ACL repair using the BEAR Implant: Provide a stable knee. Updated April 2020. eCollection 2019 Mar. PMID: 26261424; PMCID: PMC4527573. 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. PMID: 30737199. The BEAR procedure is a promising technique that will likely meet these goals. The BEAR Implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). Federal government websites often end in .gov or .mil. ACL (anterior cruciate ligament) injuries. (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. Am J Sports Med. 2017;45(1):97105. AOSSM checks author disclosures against the Open Payments Database (OPD). Am J Sports Med. 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). The intact fibers have low signal intensity (black), reflecting highly organized tissue with little free water. Bookshelf Conclusion: Background: 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. These include educational payments from Kairos Surgical (D.E.K., Y.-M.Y.) Am J Sports Med. How The BEAR Implant Works To Heal ACL Tears Paul Norio Morton, MD 2023-03-12T17:47:17-10:00 October 13, 2022 | Comments Off on How The BEAR Implant Works To Heal ACL Tears The Bridged Enhanced ACL Repair ( BEAR ) implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). -. James received a Master of Library Science degree from Dominican University. all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. Lu W, Deng Z, Essien AE, Arthur Vithran DT, Opoku M, Li Y, Xiao W. J Clin Med. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. "Torn ACLs are among the most common knee injuries in the United States," according to Capt. government site. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. 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. 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. "Today's marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.". Its not something that every patient will be eligible for, Alan Getgood, MD, an orthopedic surgeon specializing in knee reconstruction at the Fowler Kennedy Sport Medicine Clinic in Canada, tells Verywell. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. Methods: However, now a new surgical implant called BEAR is shaking up that world by offering a solution to try to regrow the torn ACL. (D) The ends of the torn ACL then grow into the scaffold, which is gradually replaced by healing ligament tissue. Orthop J Sports Med. 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. Orthopaedic Journal of Sports Medicine. 2021 Apr;29(4):518-526. doi: 10.1016/j.joca.2021.01.004. The BEAR device must be implanted within 50 days of injury. 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.