Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. Methods: 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. The BEAR implant goes into single graft tunnels drilled into the femur and tibia like ACLR surgery. Patients were randomly assigned to receive either BEAR (n = 65) or autograft ACLR (n = 35 [33 with quadrupled semitendinosus-gracilis and 2 with bone-patellar tendon-bone]). sharing sensitive information, make sure youre on a federal This change to our approach will greatly benefit our patients. Patients must have an ACL stump attached to the tibia to construct the repair. Migliorini F, Vecchio G, Eschweiler J, Schneider SM, Hildebrand F, Maffulli N. J Orthop Traumatol. Schematic of the technique used to place the BEAR implant. For the BEAR Trial Team, B.P. Harvard Health Publishing. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. Careers. Knee Surg Sports Traumatol Arthrosc. Determining the Need for Surgery When You Feel Better Post-ACL Tear, Treating a Torn ACL Knee in Children and Teens, Surgery Treatments for Knee Pain and Injuries, Why Knee Arthritis Is Likely to Develop After an ACL Tear, Using Your Own Tissue vs. Donor Graft for ACL Surgery, Tympanoplasty Surgery: Everything You Need to Know, Meniscus Tears: Symptoms, Diagnosis, and Treatment. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. Epub 2016 May 13. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. 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. Hypothesis: See this image and copyright information in PMC. The advantages are: In past decade, we have published two MRI analysis case series demonstrating good healing of the ACL with the Perc-ACLR procedure (16,17). Copyright Regenexx 2023. In total, 96% of the patients returned for 2-year follow-up. 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. The U.S. Food and Drug Administration (FDA) approved a new implant that can repair some anterior cruciate ligament (ACL) injuries. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. Epub 2013 Aug 18. April 16, 2020. doi:10.1177/0363546520913532. (12) Wirth W, Eckstein F, Culvenor AG, Hudelmaier MI, Stefan Lohmander L, Frobell RB. (9) Kamien PM, Hydrick JM, Replogle WH, Go LT, Barrett GR. 2023;9:8. doi: 10.1051/sicotj/2023007. The patient needs to have some tissue intact after the tear for the implant to work. (D) The ends of the torn ACL then grow into the scaffold, which is gradually replaced by healing ligament tissue. Study design: 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. Registration: 2018;26:1362-1366. 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. Federal government websites often end in .gov or .mil. Assessment of neuromuscular control in patients after anterior cruciate ligament reconstruction. FOIA 8600 Rockville Pike 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. 2017;45:97-105. 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. eCollection 2022 Oct. See this image and copyright information in PMC. HHS Vulnerability Disclosure, Help The nonabsorbable sutures are threaded through the BEAR scaffold and tibial tunnel and secured in place with an extracortical button. government site. PMID: 23813800. Hence, you would need a Regenexx network physician to look at your actual MRI images. 2016;44(7):16601670. 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. Age, graft size, and Tegner activity level as predictors of failure in anterior cruciate ligament reconstruction with hamstring autograft. (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. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. "ACL reconstruction is one of the most common procedures in sports medicine," said . Results: ACL reconstruction surgery has been a staple of modern sports medicine for decades. 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. The BEAR procedure is a promising technique that will likely meet these goals. These include educational payments from Kairos Surgical (D.E.K., Y.-M.Y.) Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. We think you need to have sufficient ACL tissue left to repair for the surgery with the implant to work, Murray says. Unable to load your collection due to an error, Unable to load your delegates due to an error, Stepwise demonstration of the bridge-enhanced anterior cruciate ligament repair (BEAR) technique using the scaffold. Vandenrijt J, Callenaere S, Van der Auwera D, Michielsen J, Van Dyck P, Heusdens CHW. Lets look at the positives and negatives of this new technology and compare it to the Regenexx perc-ACLR procedure. Patients report more satisfaction in terms of pain, symptoms, and readiness. Epub 2023 Jan 16. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. and transmitted securely. Orthop J Sports Med. Epub 2016 Jul 27. Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? Further work is planned sharing sensitive information, make sure youre on a federal PMID: 23959965. 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. 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. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. A patient may recover strength faster after a BEAR than traditional ACLR. U.S. Food and Drug Administration. B.L.P. Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. During surgery, the patients own blood is injected into the implant to form a device-protected clot that enables the body to heal. . Am J Sports Med. BEAR ACL repair technique shows promise for patients whose injuries are in the subset of ACL tears where the ACL still has some good substance after it is torn. Within eight weeks, the body absorbs the implant and replaces it with new tissue that gets stronger over time. February 2022. doi:10.1177/23259671211070542. 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. has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. We hypothesized that patients treated with BEAR would have a noninferior patient-reported outcomes (International Knee Documentation Committee [IKDC] Subjective Score; prespecified noninferiority margin, -11.5 points) and instrumented anteroposterior (AP) knee laxity (prespecified noninferiority margin, +2-mm side-to-side difference) and superior muscle strength at 2 years after surgery when compared with patients who underwent ACLR with autograft. When typing in this field, a list of search results will appear and be automatically updated as you type. 2023 Apr 26;10(1):49. doi: 10.1186/s40634-023-00605-z. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. Patients received physical therapy and were followed for two years. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. The BEAR Implant was cleared by the U.S. Food & Drug Administration through the De Novo Pathway. 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. 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. 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. Tissue Eng Part A. 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). PMID: 26261424; PMCID: PMC4527573. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. 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. 2006;34(1):128135. National Library of Medicine Injury must have occurred within the last 50 days. Purpose/hypothesis: The purpose of this study was to report the 12- and 24-month outcomes of patients who . Epub 2020 Jun 29. 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). 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. Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. 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. Today, the U.S. Food and Drug Administration granted marketing authorizationunder the De Novo premarket review pathwayfor an anterior cruciate ligament (ACL) implant . 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. (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. Careers. Cohort study; Level of evidence, 2. In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. PMID: 30033738; PMCID: PMC7298591. Upper left panel: A suture (purple) is placed through the tibial stump via a whipstitch and secured with 2 free sutures (green) to an extracortical button. The implant is resorbed by the body, usually within eight weeks. Li J, Rothrauff B, Chen S, Zhao S, Wu Z, Chen Q, He J. Orthop J Sports Med. 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. 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 . Annually in the United States, as many as 250,000 people suffer an ACL tear [2 . 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. 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. (7) Bczkowicz D, Skomudek A. These are: The acronym BEAR stands for Bridge Enhanced ACL Repair. Methods: Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. In 2020 Murray et al reported the outcome results of their Level I randomized-controlled trial examining a similar cohort of patients . The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. A whipstitch of No. M.M.M. . Epub 2013 Jun 28. Incidence of Second ACL Injuries 2 Years After Primary ACL Reconstruction and Return to Sport. -, Astur DC, Cachoeira CM, da Silva Vieira T, Debieux P, Kaleka CC, Cohen M. Increased incidence of anterior cruciate ligament revision surgery in paediatric verses adult population. Would you like email updates of new search results? Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. As the intra-articular environment is complex in its response to implanted materials, this study was designed to determine whether there . Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes. Thank you, {{form.email}}, for signing up. These preclinical studies were critical for obtaining FDA approval in 2014 for the first-in-human study (BEAR I), which was initiated February 2015. Y.-M.Y. No surgery, drilling, or graft tunnels are required. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. 2 nonabsorbable sutures (green sutures) and No. Results: The BEAR device must be implanted within 50 days of injury. 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. Schedule an appointment with a BEAR-MOON trial physician and find out if you qualify for the trial. 2021 Feb 3;103 (3):e14. If you have questions or comments about this blog post, please email us at [emailprotected]. The site is secure. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. Tang C, Kwaees TA, Accadbled F, Turati M, Green DW, Nicolaou N. J Child Orthop. Orthop J Sports Med. 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.
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