The technique was approved by the Food and Drug Administration in late 2020 and has been used in a handful of patients at OHSU, beginning with the first case in Oregon this past February. The BEAR Implant was granted De Novo Approval from the U.S. Food and Drug Administration in December 2020. official website and that any information you provide is encrypted Osteoarthritis Cartilage. from 8 AM - 9 PM ET. There were no graft or repair failures in the first 24 months after surgery. Age, graft size, and Tegner activity level as predictors of failure in anterior cruciate ligament reconstruction with hamstring autograft. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. Methods: ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. (D) The ends of the torn ACL then grow into the scaffold, which is gradually replaced by healing ligament tissue. 2020 Feb;44(2):365-380. doi: 10.1007/s00264-019-04417-8. 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knee's natural anatomy and function. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. The injury does not heal on its own, so ACL reconstruction is the only way to repair it. Study Goal has received educational support and hospitality payments from Kairos Surgical. doi: 10.1177/03635465221144035. 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 patients ACL. The advantages are: In past decade, we have published two MRI analysis case series demonstrating good healing of the ACL with the Perc-ACLR procedure (16,17). 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. FOIA Patients must have an ACL stump attached to the tibia to construct the repair. 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. 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. 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. Background: J Orthop Sports Phys Ther. "ACL reconstruction is one of the most common procedures in sports medicine," said . In addition, 14% of the BEAR group and 6% of the ACLR group had a reinjury that required a second ipsilateral ACL surgical procedure (P = .32). Knee. This new technique provides promise that soon surgeons will be able to repair and regenerate the ACL instead of replacing it. 2009;17:77-79. Failure rates for anterior cruciate ligament (ACL) repair are greater than those for ACL reconstruction. Am J Sports Med. 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. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. Epub 2016 Jul 27. Federal government websites often end in .gov or .mil. 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. The Football Players Health Study is funded by a grant from the National Football League (NFL) Players Association. Patients received physical therapy and were followed for two years. Li J, Rothrauff B, Chen S, Zhao S, Wu Z, Chen Q, He J. Orthop J Sports Med. The BEAR procedure is a new and different way of thinking about the surgical approach to treating ACL injuries. BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. Thank you, {{form.email}}, for signing up. Progression of osteoarthritis after double- and single-bundle anterior cruciate ligament reconstruction. (9) Kamien PM, Hydrick JM, Replogle WH, Go LT, Barrett GR. (From Murray et al.). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3. 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. The data supporting the implant is very encouraging. Fleming says it will be interesting to see if the rate of arthritis following implant insertion will be less than in patients receiving ACL reconstruction as the teams preclinical studies suggest. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. The Lifespan Orthopedics Institute is managing the only New England . 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. Duke . Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. 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 . Although ACL reconstruction is effective, the procedure has drawbacks; the . Am J Sports Med. 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. Study design: February 2022. doi:10.1177/23259671211070542. In a recently published Randomized Controlled Trial (RCT), the BEAR procedure was shown to be as good or better than ACL reconstruction surgery (1). 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. Before Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. Her discoveries led to the conceptualization of an implant that could be placed between the torn ends of the ACL to bridge the gap, which is then mixed with the patients own blood to stimulate healing. PMID: 23813800. 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. 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. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. 2023 Mar 2;12(5):1999. doi: 10.3390/jcm12051999. Share this article. That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. 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. How The BEAR Implant Works To Heal ACL Tears Paul Norio Morton, MD 2023-03-12T17:47:17-10:00 October 13, 2022 | Comments Off on How The BEAR Implant Works To Heal ACL Tears The Bridged Enhanced ACL Repair ( BEAR ) implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). Disclaimer. Martha Murray, MD, an orthopedic surgeon at Boston Childrens Hospital and professor at Harvard Medical School who spearheaded the research, notes that the implantis made of the same proteins found in the normal ACL. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. This difference in injury risk is an important focus of research and has been attributed to anatomy, hormonal effects, neuromuscular control, biomechanics, and sport participation. A comprehensive, integrated, academic health system with The Warren Alpert Medical School of Brown University, Lifespan's present partners also include Rhode Island Hospital's pediatric division, Hasbro Children's Hospital; Bradley Hospital; Newport Hospital; Gateway Healthcare; Lifespan Physician Group; and Coastal Medical. Likely lowered prevalence of early arthritis and tearing the opposite ACL as the normal biomechanics of the knee are preserved. Surgical techniques in the management of pediatric anterior cruciate ligament tears: Current concepts. If you have questions or comments about this blog post, please email us at [emailprotected]. 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. also has received multiple payments for food and beverage from various companies. Epub 2023 Apr 13. Background: Preclinical studies suggest that for complete midsubstance anterior cruciate ligament (ACL) injuries, a suture repair of the ACL augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair [BEAR]) may be a viable alternative to ACL reconstruction (ACLR). 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. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. 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). (1) 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. Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? 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. 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. 2009;17(2):162169. 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. 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). "Torn ACLs are among the most common knee injuries in the United States," according to Capt. Orthop J Sports Med. PMID: 23897997. Incidence of Second ACL Injuries 2 Years After Primary ACL Reconstruction and Return to Sport. Lets look at the positives and negatives of this new technology and compare it to the Regenexx perc-ACLR procedure. -, 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. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human; scaffold-enhanced ACL repair. (13) Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. sharing sensitive information, make sure youre on a federal Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. Recruitment for the BEAR II trial was initiated in May 2015, and enrollment was completed June 2016. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. Study design: The purpose of this study was to report the 12- and 24-month outcomes of patients who underwent the BEAR procedure compared with a nonrandomized concurrent control group who underwent ACL reconstruction (ACLR) with an autograft. 2020 08:00 AM Eastern Standard Time. These include educational payments from Kairos Surgical (D.E.K., Y.-M.Y.) (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. Why? Despite being a very common injury, until today, the only surgical treatment available for torn ACLs has been ACL reconstruction using allograft, autograft or suture-only repair. Raquel Peat PhD [1]. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. Thus, there remains a need to find a new method that is less invasive and has the potential to provide better outcomes. In Complete ACL Tears, Bridge-Enhanced ACL Repair Was Noninferior to ACL Reconstruction for Symptoms and Functioning and Knee Laxity at 2 Years. (A) The torn anterior cruciate ligament (ACL) tissue is preserved. government site. Regenexx Perc-ACLR has been performed since 2012. One or more of the authors has declared the following potential conflict of interest or source of funding: This study received funding support from the Translational Research Program at Boston Childrens Hospital, the Childrens Hospital Orthopaedic Surgery Foundation, the Childrens Hospital Sports Medicine Foundation, the Football Players Health Study at Harvard University, and the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases through grants R01-AR065462 and R01-AR056834. Network meta-analysis of knee outcomes following anterior cruciate ligament reconstruction with various types of tendon grafts. M.M.M. How can you tell which type of complete ACL tear is which? A total of 74 patients with acute proximal isolated ACL tears will be assigned in a 1:1 allocation ratio to either (I) ACL repair using cortical button fixation and additional suture augmentation or (II) ACL reconstruction using an all-inside autologous hamstring graft technique. PMC sharing sensitive information, make sure youre on a federal Based on what I have observed for MRI evidence of healing on the images shared by the company that makes the BEAR implant and physicians online trying this procedure, the ligament reconstitution is not complete until 12 months. By Kristen Fischer "This is very novel. Key Takeaways. 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. One or more of the authors has declared the following potential conflict of interest or source of funding: This work was funded by the Translational Research Program at Boston Childrens Hospital, the Childrens Orthopaedic Surgery Foundation, the Childrens Sports Medicine Foundation, and the National Institutes of Health (NIH)/National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant Nos. 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. Epub 2023 Jan 16. All rights reserved. Orthop J Sports Med. eCollection 2022 Oct. See this image and copyright information in PMC. 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. 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). 2023;9:8. doi: 10.1051/sicotj/2023007. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. D.E.K. Detailed Description: Irradiated Hamstring Tendon Allograft Versus Autograft for Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction: Midterm Clinical Outcomes. An official website of the United States government. Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. It doesnt require a second wound site to remove healthy tendon and does not involve donors. Am J Sports Med. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. J Transl Med. Propensity for Clinically Meaningful Improvement and Surgical Failure After Anterior Cruciate Ligament Repair. 2 nonabsorbable sutures (green sutures) and No. These results were key to receiving FDA clearance for the BEAR implant in December of 2020. Would you like email updates of new search results? B.L.P. J Orthop Surg (Hong Kong). This change to our approach will greatly benefit our patients. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. In total, 96% of the patients returned for 2-year follow-up. Trends in Anterior Cruciate Ligament Repair: A Bibliometric and Visualized Analysis. Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . 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. Researchers are hopeful this implant will become the new standard of care for ACL injuries. The recent trial results showed that 14% of patients required ACLR surgery despite the BEAR surgery (1). Dr. Fadale: ACL tears are among the most common knee injuries. Epub 2020 Apr 16. 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. 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 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. When Does a Partial ACL Tear Require Surgery? PMID: 20810079. BEAR is a new technique that uses a collagen scaffold instead of a graft to repair the ACL. Murray MM, Kalish LA, Fleming BC; BEAR Trial Team; Flutie B, Freiberger C, Henderson RN, Perrone GS, Thurber LG, Proffen BL, Ecklund K, Kramer DE, Yen YM, Micheli LJ. 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. The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. This research was also conducted with support from the Football Players Health Study at Harvard University. Bookshelf 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. (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. HHS Vulnerability Disclosure, Help Preclinical studies suggest that for complete midsubstance anterior cruciate ligament (ACL) injuries, a suture repair of the ACL augmented with a protein implant placed in the gap between the torn ends (bridge-enhanced ACL repair [BEAR]) may be a viable alternative to ACL reconstruction (ACLR). Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. Despite minor improvements to the procedure, clinical outcomes have not really changed. 1991;14(3):114120. Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State. is a founder, paid consultant, and equity holder in Miach Orthopaedics, Inc, which was formed to work on upscaling production of the BEAR scaffold. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001). Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. Given that most reinjuries following BEAR and ACL reconstruction occur within the first year, the long-term results are likely to remain excellent.. Schedule an appointment with a BEAR-MOON trial physician and find out if you qualify for the trial. The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. On the other hand, those in the control group had a laxity in the treated knee of 1.77 mm. (10) Song EK, Seon JK, Yim JH, Woo SH, Seo HY, Lee KB. 2021 Feb 17;103(4):358. doi: 10.2106/JBJS.20.02088. 2014;42(5):1049-1057. doi:10.1177/0363546514526139. So far, so good, Fleming reports. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. 2006;34:128-135. 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. 8600 Rockville Pike (4) King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. The nonabsorbable sutures are threaded through the BEAR scaffold and tibial tunnel and secured in place with an extracortical button. ACL, anterior cruciate ligament; BEAR, bridge-enhanced ACL repair. PMID: 32558951. Verywell Health's content is for informational and educational purposes only. 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. 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). Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. AOSSM checks author disclosures against the Open Payments Database (OPD). 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. (5) Sanborn RM, Badger GJ, Proffen B, et al. There are four primary goals to ACL repair using the BEAR Implant: Provide a stable knee. Historically, the repair method of just suturing the two ends together has not been very effective.". Hence, any implant procedure requiring tunnels to be drilled will likely harm cartilage. Would you like email updates of new search results? First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. 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. 2018;26:1362-1366. Accessibility ACL tears are often treated with surgery called ACL reconstruction. Patients must have an ACL stump attached to the tibia to construct the repair. 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. 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. Careers. Find a Surgeon. If the latter holds true in clinical patients, then the impact of the BEAR procedure will be even greater.. Bethesda, MD 20894, Web Policies NCT02664545 (ClinicalTrials.gov identifier). These patients are currently being followed to determine long term outcomes. has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical.