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. Background: 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. Schedule an appointment with a BEAR-MOON trial physician and find out if you qualify for the trial. Why? AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. 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. 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. It's a multi-center, randomized, clinical trial seeking adult participants with a torn ACL that has occurred within the past 50 days, who qualify for surgery . Results: Lu W, Deng Z, Essien AE, Arthur Vithran DT, Opoku M, Li Y, Xiao W. J Clin Med. Hence, you would need a Regenexx network physician to look at your actual MRI images. Disclaimer. 2017;45:97-105. 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. Would you like email updates of new search results? The site is secure. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Media Contact:Abby Capobianco, 240-461-9059Consumer Inquiries: [emailprotected], 888-INFO-FDA. The Most Comprehensive Orthopedic Care in the Region, Orthopedic Surgeons and Specialists in Rhode Island, Meet Our Team - Shoulder and Elbow Specialists, As Orthopedic Patients Get Younger, Procedures Get More Advanced, Meet Our Team - Sports Medicine Specialists, Meet Our Team - Orthopedic Trauma Specialists, Research Breaks Through to the Other Side of the Blood Brain Barrier, Cerebral Palsy: Enhancing Functional Recovery, ACL Research: A Q&A with Braden Fleming, PhD, Predicting Thumb Carpometacarpal Osteoarthritis, Pursuing the Promise of Smart Joint Implants, Women's Lacrosse Focus of Lifespan Bioengineering Researcher, Surgeons Persistence, Prowess Saves Fishermans Hand, Cartilage Transplant Returns Brittney to Athletic Activity, Research and Clinical Trials at the Lifespan Orthopedics Institute, Have suffered a complete ACL tear (as documented on an MRI scan by a medical professional) within the past 50 days, Were advised by a medical professional that surgery is recommended to treat the ACL tear, Are willing to follow the study instructions for return visits and rehabilitation exercises. 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. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human. 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. Epub 2020 Apr 16. Methods: all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. 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. Published Dec. 17, 2020 Greg Slabodkin Senior Editor Courtesy of Miach Orthopaedics Dive Brief: FDA has authorized a resorbable implant under the De Novo premarket review pathway that fills the gap between the torn ends of a patient's anterior cruciate ligament (ACL), one of the most common knee injuries in the U.S. J Exp Orthop. Recruitment for the BEAR MOON trial was initiated in September of 2021 and the study is currently underway. 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). government site. The implant is aimed at patients at least 14 years of age who have experienced a complete ACL rupture confirmed with magnetic resonance imaging (MRI) scan. Measurements below 3 millimeters (mm) are considered normal. Knee Surg Sports Traumatol Arthrosc. That's a big deal, because until now your ACL would have been replaced with either another tendon from your body or a tendon from a deceased donor. The BEAR Implant for ACL Tears - Regenexx 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. Hence, any implant procedure requiring tunnels to be drilled will likely harm cartilage. 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). Thank you, {{form.email}}, for signing up. These promising results suggest that longer-term studies of this technique are justified. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. Lower extremity compensatory neuromuscular and biomechanical adaptations 2 to 11 years after anterior cruciate ligament reconstruction. NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. Epub 2020 Jun 29. 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. ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). Recruitment for the BEAR II trial was initiated in May 2015, and enrollment was completed June 2016. with the inherently same conflicts. In this procedure, the torn ACL fibers are completely removed and replaced with the graft, which is inserted arthroscopically into large tunnels drilled into the knee. also has received multiple payments for food and beverage from various companies. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. During ACL reconstruction, an orthopedic surgeon removes your torn ACL and replaces it with a graft from another part of your leg (called an autograft) or a deceased donor (called an allograft). Upper right panel: After a cortical button carrying free sutures (green) is passed up through the femoral tunnel, the BEAR implant is loaded onto them and soaked with up to 10 mL of autologous blood. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Keywords: Trends in Anterior Cruciate Ligament Repair: A Bibliometric and Visualized Analysis. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL . Magnetic resonance imaging from the 9 patients in the bridge-enhanced anterior cruciate ligament repair (BEAR) group at 24 months shows intact anterior cruciate ligament (ACL) fibers from the femoral to tibial attachment sites (arrows). Knee Surg Sports Traumatol Arthrosc. 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. How is BEAR different than ACLR surgery? The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. Age, graft size, and Tegner activity level as predictors of failure in anterior cruciate ligament reconstruction with hamstring autograft. 2018;26:1362-1366. "Today's marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.". Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. Is the BEAR Implant Safe? The results were excellent (more on those below). 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. 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. 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. (17) Centeno CJ, Pitts J, Al-Sayegh H, Freeman MD. 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. Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH 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. Quantitative MRI Biomarkers to Predict Risk of Reinjury Within 2 Years After Bridge-Enhanced ACL Restoration. 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. 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. As the intra-articular environment is complex in its response to implanted materials, this study was designed to determine whether there . Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the body's own tissue. 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 . 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. How is the BEAR implant different from reconstruction? 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. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. 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. How can you tell which type of complete ACL tear is which? 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. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. 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. 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. 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. Before In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. -, 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. Patients report more satisfaction in terms of pain, symptoms, and readiness. . 2017;45(1):97105. In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. PMID: 23897997. 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.
