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 . Before Knee. 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. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. The https:// ensures that you are connecting to the Other patients showed higher signal intensity within the graft itself (eg, bottom row [third from left]), reflecting increased fluid within the graft. 2020 Jul;11(3):329-337. doi: 10.1177/1947603518790009. The data supporting the implant is very encouraging. 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. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. Li J, Rothrauff B, Chen S, Zhao S, Wu Z, Chen Q, He J. Orthop J Sports Med. PMID: 33549723. 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). 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. 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. 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. Background: Knee Surg Sports Traumatol Arthrosc. PMID: 30033738; PMCID: PMC7298591. April 16, 2020. doi:10.1177/0363546520913532. Lets look at the positives and negatives of this new technology and compare it to the Regenexx perc-ACLR procedure. A patient may recover strength faster after a BEAR than traditional ACLR. 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. J Transl Med. A whipstitch of No. eCollection 2016 Nov. 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. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. 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. AR065462 and R01AR056834). 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.. Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH (D) The ends of the torn ACL then grow into the scaffold, which is gradually replaced by healing ligament tissue. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. Regenexx Perc-ACLR has been performed since 2012. By clicking Accept All Cookies, you agree to the storing of cookies on your device to enhance site navigation, analyze site usage, and assist in our marketing efforts. Epub 2020 Apr 16. In 2020 Murray et al reported the outcome results of their Level I randomized-controlled trial examining a similar cohort of patients . 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). BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. The BEAR III trial was designed to evaluate the effects of age on outcomes following the BEAR procedure. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. "This is very novel. Third, while it's unknown if knees repaired with BEAR retain their position sense, that's much more likely than the tendon graft . Thank you, {{form.email}}, for signing up. 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. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. U.S. Food and Drug Administration. 2019 Mar 22;7(3):2325967118824356. doi: 10.1177/2325967118824356. . Murray also believes the implant will be a new gold standard for ACL repair in the future. J Orthop Surg (Hong Kong). 2023;9:8. doi: 10.1051/sicotj/2023007. The request was submitted under section 513(f)(2) of the FD&C Act. 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. sharing sensitive information, make sure youre on a federal Detailed Description: BEAR resulted in noninferior patient-reported outcomes and AP knee laxity and superior hamstring muscle strength when compared with autograft ACLR at 2-year follow-up in a young and active cohort. Additional stitching holds the device in place. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. These are: The acronym BEAR stands for Bridge Enhanced ACL Repair. I am confident that it is a viable alternative to ACL reconstruction as it does not require graft harvest, it does not compromise muscle function, and there is evidence in preclinical models that the procedure reduces arthritis,a long-termproblem associated with ACL reconstruction surgery, he says. Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. A small percentage of patients treated with the BEAR Implant re-tore their ACL when they returned to sports sooner than recommended and then had a standard ACL reconstruction. 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. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. This research was also conducted with support from the Football Players Health Study at Harvard University. Reduced knee laxity and failure rate following anterior cruciate ligament reconstruction compared with repair for acute tears: a meta-analysis. PMID: 23897997. and transmitted securely. Recruitment for the BEAR II trial was initiated in May 2015, and enrollment was completed June 2016. 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. Adam S. Lepley, PhD, co-director of the Michigan Performance Research Laboratory at the University of Michigan, who specializes in rehabilitation, noted that traditional ACL reconstruction focuses on rebuilding the ligament while the implant centers on repairing it. On June 4, 2020, FDA received your De Novo requesting classification of the BEAR (Bridge-Enhanced ACL Repair) Implant. Orthop J Sports Med. 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. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Orthop J Sports Med. Providers listed on the Regenexx website are for informational purposes only and are not a recommendation from Regenexx for a specific provider or a guarantee of the outcome of any treatment you receive. 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. The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. This change to our approach will greatly benefit our patients. When applied correctly to suitable patients, these two really shouldnt compete head to head in that they are focused on two different types of ACL injuries. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. FDA authorizes marketing of new implant to repair a torn ACL. Orthop J Sports Med. 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. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. 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. (13) Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. 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. 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. 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. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. We think you need to have sufficient ACL tissue left to repair for the surgery with the implant to work, Murray says. 2016;44(7):16601670. Epub 2013 Aug 18. BEAR is a new technique that uses a collagen scaffold instead of a graft to repair the ACL. This site needs JavaScript to work properly. Am J Sports Med. By Kristen Fischer Verywell Health's content is for informational and educational purposes only. (7) Bczkowicz D, Skomudek A. What is it? 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. D.E.K. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. 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. The bodys own tissue eventually replaces the implant. However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. The site is secure. Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes. Dr. Fleming: ACL reconstruction surgery in active patients has been the gold standard treatment for more than three decades. Arthroscopy. 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. Barnes DA, Badger GJ, Yen YM, Micheli LJ, Kramer DE, Fadale PD, Hulstyn MJ, Owens BD; BEAR Trial Team; Flannery SW, Ecklund K, Sanborn RM, Costa MQ, Chrostek C, Proffen BL, Sant N, Murray MM, Fleming BC, Kiapour AM. Dont wait. (14) Nomura Y, Kuramochi R, Fukubayashi T. Evaluation of hamstring muscle strength and morphology after anterior cruciate ligament reconstruction. The typical treatment for this injury is reconstructive surgery. (From Murray et al.). However, given that BEAR is a new technology, most surgeons are unlikely to allow a return to sports at six months. Y.-M.Y. 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. Bethesda, MD 20894, Web Policies This concept led to the development of the Bridge-Enhanced ACL Restoration (BEAR) Implant, a fundamental change in the approach to treating ACL injuries. Whether it replaces ACL reconstruction as the gold standard remains to be seen but I am optimistic it will, Fleming adds. "ACL reconstruction is one of the most common procedures in sports medicine," said . No surgery, drilling, or graft tunnels are required. Hypothesis: 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. The BEAR Implant is absorbed by the body as the ACL heals. Am J Sports Med. The recent trial results showed that 14% of patients required ACLR surgery despite the BEAR surgery (1). J Orthop Res. 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. Federal government websites often end in .gov or .mil. ________________________________________________________________. official website and that any information you provide is encrypted Bookshelf 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. 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. Careers. 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. 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. Am J Sports Med. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. Kristen Fischer is a journalist who has covered health news for more than a decade. And what does it have to do with my (ouch) torn ACL (anterior cruciate ligament)? Results: In a recently published Randomized Controlled Trial (RCT), the BEAR procedure was shown to be as good or better than ACL reconstruction surgery (1). 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. Tang C, Kwaees TA, Accadbled F, Turati M, Green DW, Nicolaou N. J Child Orthop. Most of these injuries happen to non-professional athletes. Trends in Anterior Cruciate Ligament Repair: A Bibliometric and Visualized Analysis. Because ACLs do not repair themselves, the surgeon typically uses a tendon graft from another part of the patients body to replace the ACL. Bookshelf all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. So far, so good, Fleming reports. 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. Lu W, Deng Z, Essien AE, Arthur Vithran DT, Opoku M, Li Y, Xiao W. J Clin Med. 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. Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. -. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the bodys own tissue. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 2006;34:128-135. "Torn ACLs are among the most common knee injuries in the United States," according to Capt. (15) Centeno C, Lucas M, Stemoer I, Dodson E. IMAGE-GUIDED INJECTION OF ANTERIOR CRUCIATE LIGAMENT TEARS WITH AUTOLOGOUS BONE MARROW CONCENTRATE AND PLATELETS: MIDTERM ANALYSIS FROM A RANDOMIZED CONTROLLED TRIAL. PMC 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. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL . To learn more, see my video below: Our research has shown that for the right type of tears, you end up with MRI and functional evidence of a repaired ACL. For the BEAR Trial Team, B.P. The Football Players Health Study is funded by a grant from the National Football League (NFL) Players Association. An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months; no patients in either group had C (abnormal) or D (severely abnormal) grades. Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. Updated December 16, 2020. Patients with the implant had an average that was greater by 1.61 mm in the treated knee compared to their untreated knee. Murray, M, et al. 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. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. 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. 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. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. 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. 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 . 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). Patients must have an ACL stump attached to the tibia to construct the repair. 2021 Jun;39(6):1281-1288. doi: 10.1002/jor.24783. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. The BEAR Implant is different because it works with . 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. AOSSM checks author disclosures against the Open Payments Database (OPD). HHS Vulnerability Disclosure, Help 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. The Regenexx perc-ACLR procedure should be applied in patients that have a complete ACL tear, but the two ends are still connected. 2009;17:77-79. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. Dec 16, 2020, 14:53 ET. December 16, 2020. If the repair does fail, it is much easier to fix than when a graft fails, he says. 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. One of the most important findings of her research is that performing an ACL repair is very difficult, and it explains why initial attempts in the 1970's and 1980's did not work . Disclaimer. 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. -, Anderson MA, Gieck JH, Perrin DH, Weltman A, Rutt RA, Denegar CR. 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. Benefits of BEAR ACL Repair in Pediatric Patients. 2006;34(1):128135. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. Epub 2020 Jun 25. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. For full product and risk information . As the intra-articular environment is complex in its response to implanted materials, this study was designed to determine whether there . February 2022. doi:10.1177/23259671211070542. However, now a new surgical implant called BEAR is shaking up that world by offering a solution to try to regrow the torn ACL. 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. These preclinical studies were critical for obtaining FDA approval in 2014 for the first-in-human study (BEAR I), which was initiated February 2015. (6) Patterson MR, Delahunt E. A diagonal landing task to assess dynamic postural stability in ACL reconstructed females. eCollection 2023 Apr. Am J Sports Med. Conclusion: PMID: 32558951. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. The surgery, however, is not without its problems. An official website of the United States government, Recalls, Market Withdrawals and Safety Alerts, FDA Authorizes Marketing of New Implant to Repair a Torn ACL, Office of Orthopedic Devices, Office of Product Evaluation and Quality. 2014;42(7):1567-1573. doi:10.1177/0363546514530088. Arthrometry measures the difference in laxity between a person's healthy leg and their injured leg. 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. Today, the U.S. Food and Drug Administration granted marketing authorizationunder the De Novo premarket review pathwayfor an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears. What if the anterior cruciate ligament (ACL) had the ability to repair itself? How is BEAR different than ACLR surgery? ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. 2018;26:1362-1366. Study Goal 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. Br J Sports Med. -, 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. 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 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. FOIA 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. Miach Orthopaedics Inc., a privately held company dedicated to developing bio-engineered surgical implants for connective tissue repair, today announced that the U.S. Food & Drug Administration has granted the company's De Novo Request for the Bridge-Enhanced ACL Repair (BEAR) Implant, resulting in marketing approval for the treatment of anterior cruciate ligament (ACL) tears, one of the . 1991;14(3):114120. -, Akelman MR, Fadale PD, Hulstyn MJ, et al. Would you like email updates of new search results? AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. 2 nonabsorbable sutures (green sutures) and No. 2023 Feb 20;24(1):8. doi: 10.1186/s10195-023-00688-5. Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. 2015 Jun;25(3):301-7. doi: 10.1111/sms.12205. The results were excellent (more on those below). 90 clinic locations offering non-surgical Regenexx solutions for musculoskeletal pain.