However, given that BEAR is a new technology, most surgeons are unlikely to allow a return to sports at six months. 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. 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. 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. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. Epub 2023 Apr 13. Copyright Regenexx 2023. from 8 AM - 9 PM ET. By Kristen Fischer 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 . The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. The patient needs to have some tissue intact after the tear for the implant to work. The BEAR Implant for ACL Tears - Regenexx Patients must have an ACL stump attached to the tibia to construct the repair. The BEAR procedure is a promising technique that will likely meet these goals. 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. The https:// ensures that you are connecting to the Methods: 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. 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. (A) The torn anterior cruciate ligament (ACL) tissue is preserved. Murray, M, et al. Unauthorized use of these marks is strictly prohibited. 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. These promising results suggest that longer-term studies of this technique are justified. We hypothesized that the BEAR group would have physical examination findings, patient-reported outcomes, and adverse events that were similar to those of the ACLR group. 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. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. This is a potential problem as the natural ACL has two bands that cross each other (hence the name Cruciate, which in Latin means cross). R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. PMID: 32298131; PMCID: PMC7227128. 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. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Healths Office of Orthopedic Devices, Todays marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.. Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. The upshot? Key Takeaways. Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. In total, 96% of the patients returned for 2-year follow-up. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. 2021 Feb 17;103(4):358. doi: 10.2106/JBJS.20.02088. Knee extension and flexion muscle power after anterior cruciate ligament reconstruction with patellar tendon graft or hamstring tendons graft: a cross-sectional comparison 3 years post surgery. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. 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. and food, beverage, and travell reimbursements from 5 companies (each <$500). 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. Epub 2016 May 13. has patents/patents pending for the BEAR technology from Boston Childrens Hospital and Rhode Island Hospital, is a paid associate editor for The American Journal of Sports Medicine, has received royalties from Springer, and has received research grants from the NIH and the Department of Defense. Fourth, there is no need to take a tendon graft with BEAR, so things like hamstrings and quadriceps weakness are avoided. Kristen Fischer is a journalist who has covered health news for more than a decade. government site. Patients must have an ACL stump attached to the tibia to construct the repair. (4) King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. Find a Surgeon. 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. 2023 Feb;17(1):12-21. doi: 10.1177/18632521221149059. See this image and copyright information in PMC. . Murray also believes the implant will be a new gold standard for ACL repair in the future. Bethesda, MD 20894, Web Policies Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. M.M.M. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Health's Office of Orthopedic Devices. In 2020 Murray et al reported the outcome results of their Level I randomized-controlled trial examining a similar cohort of patients . The Regenexx perc-ACLR procedure should be applied in patients that have a complete ACL tear, but the two ends are still connected. That tendon is secured in the tunnels and now serves as a replacement ligament. This allows for ACL 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. And what does it have to do with my (ouch) torn ACL (anterior cruciate ligament)? However, now a new surgical implant called BEAR is shaking up that world by offering a solution to try to regrow the torn ACL. 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. Keywords: Meaning these patients return to sports just like those who get ACLR surgery. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. 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. 2020 Jul;11(3):329-337. doi: 10.1177/1947603518790009. Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for Comparable Instrumented Knee Joint Laxity and Patient-Reported Outcomes After ACL Repair: Response. The BEAR Implant is absorbed by the body as the ACL heals. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. 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]). Background: Cision Distribution 888-776-0942 FOIA 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. (10) Song EK, Seon JK, Yim JH, Woo SH, Seo HY, Lee KB. Patients report more satisfaction in terms of pain, symptoms, and readiness. 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. All content provided in this blog, website, or any linked materials, including text, graphics, images, patient profiles, outcomes, and information, are not intended and should not be considered or used as a substitute for medical advice, diagnosis, or treatment. 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. has manufactured the scaffolds used in the trials at Boston Childrens Hospital and is a paid consultant and equity holder in Miach Orthopaedics at this time, as he assists with transfer of the manufacturing process to the contract manufacturing organization that Miach has engaged to do the manufacturing. What if the anterior cruciate ligament (ACL) had the ability to repair itself? Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. Purpose/hypothesis: Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH The Football Players Health Study is funded by a grant from the National Football League (NFL) Players Association. 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. Patients received physical therapy and were followed for two years. Between 2006-2012, doctors and researchers with Rhode Island Hospital, Brown University, and Boston Childrens, collaborated for a series of preclinical studies that were performed to optimize the implant, to demonstrate the safety of its use in the body, and to show that it stimulated the ACL to heal. Is the BEAR Implant Safe? The ACL, a ligament located with the knee, is the tissue responsible for bridging the shinbone to the thigh bone. How can you tell which type of complete ACL tear is which? 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. Yang XG, Wang F, He X, Feng JT, Hu YC, Zhang H, Yang L, Hua K. Int Orthop. "This is very novel. The .gov means its official. The nonabsorbable sutures are threaded through the BEAR scaffold and tibial tunnel and secured in place with an extracortical button. Likely lowered prevalence of early arthritis and tearing the opposite ACL as the normal biomechanics of the knee are preserved. 2006;34:128-135. Conclusion: Hypothesis: 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 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. FDA authorizes marketing of new implant to repair a torn ACL. Early anterior cruciate ligament reconstruction does not affect 5 year change in knee cartilage thickness: secondary analysis of a randomized clinical trial. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Federal government websites often end in .gov or .mil. M.M.M. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. 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. The BEAR implant is then injected with autologous whole blood. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI.
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