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. eCollection 2022 Oct. See this image and copyright information in PMC. . eCollection 2023 Apr. 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: 32558951. The IKDC subjective scores in both groups improved significantly from baseline (P < .0001) at 12 and 24 months, to 84.6 17.2 in the ACLR group and to 91.7 11.7 in the BEAR group. During that time, we have observed that younger patients are ready to return to sports at four months, with older patients at six months. Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. On June 4, 2020, FDA received your De Novo requesting classification of the BEAR (Bridge-Enhanced ACL Repair) Implant. Epub 2013 Aug 19. 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. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. Lu W, Deng Z, Essien AE, Arthur Vithran DT, Opoku M, Li Y, Xiao W. J Clin Med. For full product and risk information . When the trial showed that no major complications occurred, the FDA granted approval for a second study (BEAR II) comparing outcomes of patients receiving BEAR to those receiving ACL reconstruction graft (the gold standard). Recruitment for the BEAR II trial was initiated in May 2015, and enrollment was completed June 2016. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human; scaffold-enhanced ACL repair. 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 FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. Third, while it's unknown if knees repaired with BEAR retain their position sense, that's much more likely than the tendon graft . Registration: Unauthorized use of these marks is strictly prohibited. So hopefully, well see more ACL repair than tendon grafts in the near future! Li J, Rothrauff B, Chen S, Zhao S, Wu Z, Chen Q, He J. Orthop J Sports Med. Am J Sports Med. AR065462 and R01AR056834). Purpose/hypothesis: The purpose of this study was to report the 12- and 24-month outcomes of patients who . For the BEAR Trial Team, B.P. PMID: 32298131; PMCID: PMC7227128. 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. Patients must have an ACL stump attached to the tibia to construct the repair. Epub 2023 Apr 13. It can also be done via sutures, a medical device used to hold body tissues together. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. FOIA Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the bodys own tissue. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. 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. 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. What if you could skip the surgery and instead have your Bone Marrow Concentrate (BMC), which contains healing stem cells, injected into your ACL? In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. (9) Kamien PM, Hydrick JM, Replogle WH, Go LT, Barrett GR. "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. 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. PMID: 30176875; PMCID: PMC6122476. The data supporting the implant is very encouraging. 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. 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. This site needs JavaScript to work properly. Assessment of neuromuscular control in patients after anterior cruciate ligament reconstruction. Recruitment for the BEAR MOON trial was initiated in September of 2021 and the study is currently underway. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Measurements below 3 millimeters (mm) are considered normal. Bethesda, MD 20894, Web Policies 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. 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. Furthermore, the 8 patients who converted from BEAR to ACLR in the study period and returned for the 2-year postoperative visit had similar primary outcomes to patients who had a single ipsilateral ACL procedure. 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 . -, Anderson MA, Gieck JH, Perrin DH, Weltman A, Rutt RA, Denegar CR. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Health's Office of Orthopedic Devices. Effect of matching or overconstraining knee laxity during anterior cruciate ligament reconstruction on knee osteoarthritis and clinical outcomes: a randomized controlled trial with 84-month follow-up. Dr. Fleming: ACL reconstruction surgery in active patients has been the gold standard treatment for more than three decades. 8600 Rockville Pike 2023 Mar;51(3):NP12-NP14. Copyright Regenexx 2023. (A) The torn anterior cruciate ligament (ACL) tissue is preserved. All rights reserved. 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. Study design: 2014;42(7):1567-1573. doi:10.1177/0363546514530088. -, 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. 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. Small tunnels (4 mm) are drilled in the femur and tibia, and a cortical button with two No. However, now a new surgical implant called BEAR is shaking up that world by offering a solution to try to regrow the torn ACL. 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. The BEAR Implant is different because it works with . -, Akelman MR, Fadale PD, Hulstyn MJ, et al. 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. B.C.F. 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. Keywords: When a patient tears the Anterior Cruciate Ligament (ACL) in the knee and physical therapy cannot return that individual to sports, ACL reconstruction surgery (ACLR) is usually the next step. (B) The scaffold is then saturated with 5 to 10 mL of the patients blood, and (C) the tibial stump is pulled up into the saturated scaffold. (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. (8) Nyland J, Klein S, Caborn DN. National Library of Medicine 2021 Feb 3;103 (3):e14. Results: 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. 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. The BEAR Implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). PMID: 30737199. The new implant instead is made of proteins that are an integral part of the healing process, Braden Fleming, PhD, a professor of orthopedics at Brown University involved in the research, tells Verywell. Patients must have an ACL stump attached to the tibia to construct the repair. Orthop J Sports Med. Cohort study; Level of evidence, 2. What if the anterior cruciate ligament (ACL) had the ability to repair itself? 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. 2019 Mar 22;7(3):2325967118824356. doi: 10.1177/2325967118824356. Clinical Research Progress of Internal Brace Ligament Augmentation Technique in Knee Ligament Injury Repair and Reconstruction: A Narrative Review. is a founder, paid consultant, and equity holder in Miach Orthopaedics, Inc, which was formed to work on upscaling production of the BEAR scaffold. The request was submitted under section 513(f)(2) of the FD&C Act. Fleming says research is ongoing at Boston Children's Hospital, University Orthopedics, and Rhode Island Hospital to determine if there are specific patients that may do particularly well or may not do as well following the BEAR procedure. 2020 Feb;44(2):365-380. doi: 10.1007/s00264-019-04417-8. J Orthop Res. Ortop Traumatol Rehabil. 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. An erratum has been published: J Bone Joint Surg Am. Murray also believes the implant will be a new gold standard for ACL repair in the future. In addition, the retear rate that were about to publish is lower for Perc-ACLR than BEAR, and most of our patients end up with a natural double-bundle repair which is less likely with BEAR. 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. The study will continue to monitor knee stability and outcomes for 10 years following the procedure, with 9 post-operative visits taking place throughout the duration of . Cision Distribution 888-776-0942 Tissue Eng Part A. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Irradiated Hamstring Tendon Allograft Versus Autograft for Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction: Midterm Clinical Outcomes. Like the ACLR surgery, the BEAR implant only focuses on repairing a single bundle, so the knee is more likely to remain rotationally unstable. 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.