These include educational payments from Kairos Surgical (D.E.K., Y.-M.Y.) Epub 2023 Apr 13. Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. Tissue Eng Part A. 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. This research study is approved by the FDA and funded by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. 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. Despite minor improvements to the procedure, clinical outcomes have not really changed.
Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not - PubMed Am J Sports Med. 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. Am J Sports Med. Lower extremity compensatory neuromuscular and biomechanical adaptations 2 to 11 years after anterior cruciate ligament reconstruction. National Library of Medicine A piece of hamstring or quadriceps tendon is harvested, and then graft tunnels are drilled into the femur and tibia. The patient needs to have some tissue intact after the tear for the implant to work. Updated December 17, 2020. PMID: 30033738; PMCID: PMC7298591. National Library of Medicine Epub 2018 Jul 22. During surgery, the patients own blood is injected into the implant to form a device-protected clot that enables the body to heal. Vandenrijt J, Callenaere S, Van der Auwera D, Michielsen J, Van Dyck P, Heusdens CHW. 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. ACL injuries are among the most common knee injuries and affect around 400,000 Americans each year. How can you tell which type of complete ACL tear is which? 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3. Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. Scand J Med Sci Sports. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. Bookshelf Quantitative MRI Biomarkers to Predict Risk of Reinjury Within 2 Years After Bridge-Enhanced ACL Restoration. 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. BEAR is a new technique that uses a collagen scaffold instead of a graft to repair the ACL. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. official website and that any information you provide is encrypted ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair. 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. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Raquel Peat PhD [1]. In Complete ACL Tears, Bridge-Enhanced ACL Repair Was Noninferior to ACL Reconstruction for Symptoms and Functioning and Knee Laxity at 2 Years. Bethesda, MD 20894, Web Policies What is it? Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. Finally, returning to play is likely much quicker for a precise image-guided injection than the BEAR surgery. Failure rates for anterior cruciate ligament (ACL) repair are greater than those for ACL reconstruction. Assuming that orthopedic surgeons apply BEAR to the correct patients, these two procedures should never really compete head to head. Bridge-enhanced anterior cruciate ligament repair is not inferior to autograft anterior cruciate ligament reconstruction at 2 years: results of a prospective randomized clinical trial. 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.
NFL player-backed implant to fix ACL tears gets FDA De Novo PMID: 26261424; PMCID: PMC4527573. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg.
Commercial Availability of BEAR Implant - Miach Orthopaedics government site. 2015 Jun;25(3):301-7. doi: 10.1111/sms.12205. Thus, there remains a need to find a new method that is less invasive and has the potential to provide better outcomes. HHS Vulnerability Disclosure, Help Annually in the United States, as many as 250,000 people suffer an ACL tear [2 .
Comparable outcomes seen for bridge-enhanced ACL repair - Healio Please enable it to take advantage of the complete set of features! The BEAR-MOON trial addresses the question of whether this new and less invasive surgical procedure can provide non-inferior outcomes to the gold standard of treatment in terms of knee laxity, a common test to evaluate the integrity of the ACL, and patient-reported outcomes. Osteoarthritis Cartilage. Verywell Health's content is for informational and educational purposes only. That tendon is secured in the tunnels and now serves as a replacement ligament. 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. For full product and risk information . 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. The BEAR procedure is a new and different way of thinking about the surgical approach to treating ACL injuries. Dec 16, 2020, 14:53 ET. J Pain Res. PMID: 30176875; PMCID: PMC6122476. D.E.K. (17) Centeno CJ, Pitts J, Al-Sayegh H, Freeman MD. If the latter holds true in clinical patients, then the impact of the BEAR procedure will be even greater.. 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). Small tunnels (4 mm) are drilled in the femur and tibia, and a cortical button with two No. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. 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. eCollection 2019 Mar. Am J Sports Med. 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). Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . The .gov means its official. (12) Wirth W, Eckstein F, Culvenor AG, Hudelmaier MI, Stefan Lohmander L, Frobell RB. PMID: 23813800. In theory, this is ideal, as it would be healing of native tissue to the knee and not require injuring a different portion of the body to just fix another, Lepley tells Verywell. 2023;9:8. doi: 10.1051/sicotj/2023007. This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant.
Bridge-Enhanced ACL Repair (BEAR) | Lifespan How The BEAR Implant Works To Heal ACL Tears has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. 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). -, Arneja S, Leith J. 2016 Oct;44(10):2579-2588. doi: 10.1177/0363546516655333. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. Measurements below 3 millimeters (mm) are considered normal. Study design: However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. Updated December 16, 2020. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. The https:// ensures that you are connecting to the This new technique provides promise that soon surgeons will be able to repair and regenerate the ACL instead of replacing it. Additional stitching holds the device in place. "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. Kristen Fischer is a journalist who has covered health news for more than a decade. 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 . Share this article. By Kristen Fischer . Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you. with the inherently same conflicts. Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? Federal government websites often end in .gov or .mil. In a statement, Martha Shadan, president and CEO of Miach Orthopaedics, said the implant represented the first substantial advancement in the treatment of ACL tears in decades. and transmitted securely. Lower right panel: The sutures and extracortical buttons are secured. eCollection 2022 Oct. See this image and copyright information in PMC. Tang C, Kwaees TA, Accadbled F, Turati M, Green DW, Nicolaou N. J Child Orthop. Because ACLs do not repair themselves, the surgeon typically uses a tendon graft from another part of the patients body to replace the 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.
Anterior Cruciate Ligament Repair: The Current Status : JBJS - LWW Schematic of the technique used to place the BEAR implant. The Regenexx perc-ACLR procedure should be applied in patients that have a complete ACL tear, but the two ends are still connected. The BEAR Implant was granted De Novo Approval from the U.S. Food and Drug Administration in December 2020. BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. Network meta-analysis of knee outcomes following anterior cruciate ligament reconstruction with various types of tendon grafts. (16) Centeno C, Markle J, Dodson E, Stemper I, Williams C, Hyzy M, Ichim T, Freeman M. Symptomatic anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow concentrate and platelet products: a non-controlled registry study. 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. 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. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto.
Find a Surgeon - ACL Implant and Treatment Options | BEAR Implant First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. Bethesda, MD 20894, Web Policies Thank you, {{form.email}}, for signing up. A more heterogeneous appearance is present in several patients (eg, top row [third from left]) with central low signal intensity and peripheral high signal intensity (lighter gray), indicating surrounding edema. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Federal government websites often end in .gov or .mil. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. Patients must have an ACL stump attached to the tibia to construct the repair. 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. Please enable it to take advantage of the complete set of features! Epub 2016 May 13. Dr. Hulstyn: Female athletes are at 2-8 times greater risk of primary ACL injury compared with males, even when controlling for sport and competition level. The BEAR implant goes into single graft tunnels drilled into the femur and tibia like ACLR surgery. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. Irradiated Hamstring Tendon Allograft Versus Autograft for Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction: Midterm Clinical Outcomes. 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.
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