Read our. BEAR should be applied in patients with complete retracted tears, which means that the two ends of the torn ACL dont connect and have pulled back like a rubber band. 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. Murray also believes the implant will be a new gold standard for ACL repair in the future. 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.. This quicker return to play likely represents a less severe tear type for Perc-ACLR and the use of more powerful bone marrow concentrate versus whole blood for BEAR. 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. However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. Thus, there remains a need to find a new method that is less invasive and has the potential to provide better outcomes. Duke . 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. 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. 2020 Feb;44(2):365-380. doi: 10.1007/s00264-019-04417-8. HHS Vulnerability Disclosure, Help 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 patient's ACL. Epub 2020 Jun 25. FDA authorizes marketing of new implant to repair a torn ACL. PMID: 30176875; PMCID: PMC6122476. Epub 2013 Aug 18. Knee Surg Sports Traumatol Arthrosc. 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. On the other hand, those in the control group had a laxity in the treated knee of 1.77 mm. Knee Surg Sports Traumatol Arthrosc. Posterior cruciate ligament repair seems safe with low failure rates but more high level evidence is needed: a systematic review. Would you like email updates of new search results? Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the bodys own tissue. Unauthorized use of these marks is strictly prohibited. The peripheral higher signal intensity (lighter gray) indicates increased higher water content in the tissues surrounding the repaired ACL. Detailed Description: Batista JP, Maestu R, Barbier J, Chahla J, Kunze KN. 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. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. 2021 Feb 3;103 (3):e14. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. Patients must have an ACL stump attached to the tibia to construct the repair. 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. 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. The problem is that the recent research from Harvard shows that drilling these graft tunnels likely means a significant second severe inflammatory hit to the cartilage (2-4). 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. Updated April 2020. What if you could skip the surgery and instead have your Bone Marrow Concentrate (BMC), which contains healing stem cells, injected into your ACL? D.E.K. For those looking for a tried and tested method, and who may need to get back to activity quickly, they may want to stick with a traditional ACL repair, Getgood says. AR065462 and R01AR056834). PMID: 32558951. Given the promising results of the BEAR procedure in the BEAR I and BEAR II trials, two additional studies were approved by the FDA the BEAR III trial and the BEAR-MOON trial. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. FDA Authorizes Marketing of New Implant to Repair a Torn ACL 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 . BEAR is a new technique that uses a collagen scaffold instead of a graft to repair the ACL. 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]). Study Goal J Orthop Surg (Hong Kong). Lower left panel: The free suture ends (green) at the tibial end of the BEAR implant (which was positioned between the 2 ends of the torn ACL) are passed through the tibial tunnel to be tied over a second extracortical button. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. Epub 2020 Apr 16. Females Have Earlier Muscle Strength and Functional Recovery After (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. BEAR: An Innovative Solution for an ACL Tear A piece of hamstring or quadriceps tendon is harvested, and then graft tunnels are drilled into the femur and tibia. 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). Am J Sports Med. Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. 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. official website and that any information you provide is encrypted 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. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. "We are working hard to determine if there are specific factors that would identify patients who would be ideal candidates, Fleming says. An erratum has been published: J Bone Joint Surg Am. Thats the Regenexx Perc-ACLR procedure (Percutaneous ACL Repair). 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. Small tunnels (4 mm) are drilled in the femur and tibia, and a cortical button with two No. 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. -, 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. The patient's own blood is injected into the implant during the surgical implantation procedure with the intent of forming a device-protected clot that enables the body's healing process. 2016;44(7):16601670. and food, beverage, and travell reimbursements from 5 companies (each <$500). 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. Study design: 8600 Rockville Pike Disclaimer. April 16, 2020. doi:10.1177/0363546520913532. (HealthDay)An anterior cruciate ligament (ACL) implant that offers an alternative to traditional ACL reconstruction has received marketing authorization from the U.S. Food and Drug. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. The BEAR implant is then injected with autologous whole blood. 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. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. 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. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. On June 4, 2020, FDA received your De Novo requesting classification of the BEAR (Bridge-Enhanced ACL Repair) Implant. Epub 2020 Apr 16. Key Takeaways. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. For full product and risk information . Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. How is BEAR different than ACLR surgery? all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. BEAR-MOON? All rights reserved. government site. There were no graft or repair failures in the first 24 months after surgery. Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial. That tendon is secured in the tunnels and now serves as a replacement ligament. Results: has received educational support and hospitality payments from Kairos Surgical. The intact fibers have low signal intensity (black), reflecting highly organized tissue with little free water. Bethesda, MD 20894, Web Policies The Football Players Health Study is funded by a grant from the National Football League (NFL) Players Association. 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. Bridge-Enhanced ACL Repair vs ACL Reconstruction When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Am J Sports Med. Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for Lu W, Deng Z, Essien AE, Arthur Vithran DT, Opoku M, Li Y, Xiao W. J Clin Med. When typing in this field, a list of search results will appear and be automatically updated as you type. Bookshelf Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. -, Anderson MA, Gieck JH, Perrin DH, Weltman A, Rutt RA, Denegar CR. 2006;34:128-135. Lifespan, Rhode Island's first health system, was founded in 1994 by Rhode Island Hospital and the Miriam Hospital. Meaning these patients return to sports just like those who get ACLR surgery. *DISCLAIMER: Like all medical procedures, Regenexx Procedures have a success and failure rate. (7) Bczkowicz D, Skomudek A. How can you tell which type of complete ACL tear is which? Am J Sports Med. Am J Sports Med. Clipboard, Search History, and several other advanced features are temporarily unavailable. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. Epub 2020 Jun 29. has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. 2023 Apr 26;10(1):49. doi: 10.1186/s40634-023-00605-z. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. Br J Sports Med. 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. 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. FDA OKs Miach Orthopaedics' BEAR Implant for ACL Tears 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. 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 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. 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 . 2014;42(7):1567-1573. doi:10.1177/0363546514530088. It is a . PMID: 32298131; PMCID: PMC7227128. Further work is planned Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. B.C.F. ACL injuries are among the most common knee injuries and affect around 400,000 Americans each year. Patients must have an ACL stump attached to the tibia to construct the repair. ________________________________________________________________. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. Fourth, there is no need to take a tendon graft with BEAR, so things like hamstrings and quadriceps weakness are avoided. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. Would you like email updates of new search results? The .gov means its official.Federal government websites often end in .gov or .mil. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human. Find a Surgeon - ACL Implant and Treatment Options | BEAR Implant Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. The Lifespan Orthopedics Institute is managing the only New England . Keywords: For the BEAR Trial Team, B.P. The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction. BEAR represents a move toward a less invasive and equally effective surgical treatment for patients with ACL injuries.. Network meta-analysis of knee outcomes following anterior cruciate ligament reconstruction with various types of tendon grafts. Bridge-Enhanced ACL Repair (BEAR) | Lifespan . BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Cartilage. Please enable it to take advantage of the complete set of features! 2017;45(1):97105. D.E.K., L.J.M., and Y.-M.Y. Stepwise demonstration of the bridge-enhanced, Stepwise demonstration of the bridge-enhanced anterior cruciate ligament repair (BEAR) technique using the, Magnetic resonance imaging from the 9 patients in the bridge-enhanced anterior cruciate ligament, Magnetic resonance imaging from the 7 patients in the anterior cruciate ligament reconstruction, MeSH Results: Patients with the implant had an average that was greater by 1.61 mm in the treated knee compared to their untreated knee.
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