The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. Would you like email updates of new search results? Patients must have an ACL stump attached to the tibia to construct the repair. FDA authorizes marketing of new implant to repair a torn ACL. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. Assuming that orthopedic surgeons apply BEAR to the correct patients, these two procedures should never really compete head to head. 2023 Mar;51(3):NP12-NP14. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Am J Sports Med. Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. 2021 Apr;29(4):518-526. doi: 10.1016/j.joca.2021.01.004. We published the first half of a Randomized Controlled Trial last year and have completed that trial, with the full study to be published this year (15). Epub 2023 Jan 13. Epub 2014 Mar 20. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. J Transl Med. In a randomized controlled trial of 100 people who experienced complete ACL rupture, 65 received the implant and 35 members in a control group had reconstruction via autograft, using tendon from their own bodies. Every patient underwent physical therapy after surgery, and the team followed them for two years. This new technique provides promise that soon surgeons will be able to repair and regenerate the ACL instead of replacing it. The most significant differences are that BEAR still requires surgery, and the Regenexx Perc-ACLR procedure is a precise image-guided injection. The U.S. Food and Drug Administration (FDA) approved a new implant that can repair some anterior cruciate ligament (ACL) injuries. (12) Wirth W, Eckstein F, Culvenor AG, Hudelmaier MI, Stefan Lohmander L, Frobell RB. J Pain Res. 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. CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study. Kristen Fischer is a journalist who has covered health news for more than a decade. 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. PMID: 33549723. The site is secure. Find a Surgeon. An official website of the United States government. Study design: Disclaimer. Progression of osteoarthritis after double- and single-bundle anterior cruciate ligament reconstruction. PMC 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. 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. The .gov means its official.Federal government websites often end in .gov or .mil. PMID: 30737199. 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. 8600 Rockville Pike 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. 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. 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 . 2 nonabsorbable sutures (green sutures) and No. -. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the body's own tissue. 2017;45:97-105. When typing in this field, a list of search results will appear and be automatically updated as you type. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. As the intra-articular environment is complex in its response to implanted materials, this study was designed to determine whether there . Arthrometer testing demonstrated mean side-to-side differences in AP laxity that were similar in the 2 groups at 24 months (BEAR, 1.94 2.08 mm; ACLR, 3.14 2.66 mm). These preclinical studies were critical for obtaining FDA approval in 2014 for the first-in-human study (BEAR I), which was initiated February 2015. (3) Hunt ER, Jacobs CA, Conley CE, Ireland ML, Johnson DL, Lattermann C. Anterior cruciate ligament reconstruction reinitiates an inflammatory and chondrodegenerative process in the knee joint. The patients were also measured using an arthrometer, which measures the range of movement in a joint. The BEAR Implant is different because it works with . 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. NCT02664545 (ClinicalTrials.gov identifier). 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. Preserve and heal the . 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. Additional stitching holds the device in place. 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). Like the ACLR surgery, the BEAR implant only focuses on repairing a single bundle, so the knee is more likely to remain rotationally unstable. Epub 2023 Jan 16. What if the anterior cruciate ligament (ACL) had the ability to repair itself? Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. 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. No surgery, drilling, or graft tunnels are required. PMID: 23959965. M.M.M. This site needs JavaScript to work properly. The data supporting the implant is very encouraging. More information about this clinical trial and the BEAR ACL restoration procedure is available at www.bearmoon.org. It doesnt require a second wound site to remove healthy tendon and does not involve donors. Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? is an assistant editor for The American Journal of Sports Medicine, the spouse of M.M.M. What is it? The .gov means its official. 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. 2009;17(2):162169. 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. Careers. 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. Patients must have an ACL stump attached to the tibia to construct the repair. Murray also believes the implant will be a new gold standard for ACL repair in the future. That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. However, the BEAR technology has the potential to transform the way we treat ACL injuries, with restoration of the native ligament and without the need to harvest a graft from another part of the knee. 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. In a recently published Randomized Controlled Trial (RCT), the BEAR procedure was shown to be as good or better than ACL reconstruction surgery (1). 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. 1991;14(3):114120. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. 90 clinic locations offering non-surgical Regenexx solutions for musculoskeletal pain. 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. -, Arneja S, Leith J. An official website of the United States government. By Kristen Fischer 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. 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. Am J Sports Med. There are four primary goals to ACL repair using the BEAR Implant: Provide a stable knee. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. Am J Sports Med. And what does it have to do with my (ouch) torn ACL (anterior cruciate ligament)? Accessibility Cision Distribution 888-776-0942 Epub 2019 Dec 19. 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. A patient may recover strength faster after a BEAR than traditional ACLR. 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. government site. April 16, 2020. doi:10.1177/0363546520913532. Determining the Need for Surgery When You Feel Better Post-ACL Tear, Treating a Torn ACL Knee in Children and Teens, Surgery Treatments for Knee Pain and Injuries, Why Knee Arthritis Is Likely to Develop After an ACL Tear, Using Your Own Tissue vs. Donor Graft for ACL Surgery, Tympanoplasty Surgery: Everything You Need to Know, Meniscus Tears: Symptoms, Diagnosis, and Treatment. Furthermore, the 8 patients who converted from BEAR to ACLR in the study period and returned for the 2-year postoperative visit had similar primary outcomes to patients who had a single ipsilateral ACL procedure. 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. BEAR may result in knee stability and patient-reported outcomes at 2 years sufficient to warrant longer term studies of efficacy in larger groups of patients. Methods: The International Knee Documentation Committee subjective knee evaluation form: normative data. Orthop J Sports Med. (D) The ends of the torn ACL then grow into the scaffold, which is gradually replaced by healing ligament tissue. (B) The scaffold is then saturated with 5 to 10 mL of the patients blood, and (C) the tibial stump is pulled up into the saturated scaffold. also has received multiple payments for food and beverage from various companies. Patients received physical therapy and were followed for two years. Epub 2020 Apr 16. Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. Orthop J Sports Med. Age, graft size, and Tegner activity level as predictors of failure in anterior cruciate ligament reconstruction with hamstring autograft. These results were key to receiving FDA clearance for the BEAR implant in December of 2020. James received a Master of Library Science degree from Dominican University. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). 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. When Does a Partial ACL Tear Require Surgery? 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. 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 . 2023 Feb;17(1):12-21. doi: 10.1177/18632521221149059. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Schematic of the technique used to place the BEAR implant. Incidence of Second ACL Injuries 2 Years After Primary ACL Reconstruction and Return to Sport. Please enable it to take advantage of the complete set of features! 2023;9:8. doi: 10.1051/sicotj/2023007. 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. The new implant instead is made of proteins that are an integral part of the healing process, Braden Fleming, PhD, a professor of orthopedics at Brown University involved in the research, tells Verywell. Noninferiority criteria were met for both the IKDC Subjective Score (BEAR, 88.9 points; ACLR, 84.8 points; mean difference, 4.1 points [95% CI, -1.5 to 9.7]) and the side-to-side difference in AP knee laxity (BEAR, 1.61 mm; ACLR, 1.77 mm; mean difference, -0.15 mm [95% CI, -1.48 to 1.17]). ACL injuries are among the most common knee injuries and affect around 400,000 Americans each year. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. 33,34 The scaffold is used to bridge the . 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. National Library of Medicine However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. Despite minor improvements to the procedure, clinical outcomes have not really changed. 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. Patients must have an ACL stump attached to the tibia to construct the repair. So hopefully, well see more ACL repair than tendon grafts in the near future! J Exp Orthop. J Orthop Surg (Hong Kong). 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. PMID: 26261424; PMCID: PMC4527573. Please always consult with a professional and certified healthcare provider to discuss if a treatment is right for you. The nonabsorbable sutures are threaded through the BEAR scaffold and tibial tunnel and secured in place with an extracortical button. 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. L.J.M. 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 2019 Mar 22;7(3):2325967118824356. doi: 10.1177/2325967118824356. Orthopaedic Journal of Sports Medicine. M.M.M. BEAR represents a move toward a less invasive and equally effective surgical treatment for patients with ACL injuries.. Meaning these patients return to sports just like those who get ACLR surgery. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. 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. Purpose/hypothesis: The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. This change to our approach will greatly benefit our patients. doi: 10.1177/03635465221144035. 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. eCollection 2019 Mar. "This is very novel. 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. J Orthop Res. The request was submitted under section 513(f)(2) of the FD&C Act. The https:// ensures that you are connecting to the We hypothesized that female sex would have significantly worse early functional outcomes and higher retear rates following primary repair of the ACL enhanced with a tissue-engineered scaffold . B.C.F. 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 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. Lu W, Deng Z, Essien AE, Arthur Vithran DT, Opoku M, Li Y, Xiao W. J Clin Med. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. 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. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. Recruitment for the BEAR MOON trial was initiated in September of 2021 and the study is currently underway. 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. December 16, 2020. Review article: validity of the KT-1000 knee ligament arthrometer. There were no graft or repair failures in the first 24 months after surgery. Federal government websites often end in .gov or .mil. The BEAR III trial was designed to evaluate the effects of age on outcomes following the BEAR procedure. 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. Please enable it to take advantage of the complete set of features! Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. FOIA B.C.F. The https:// ensures that you are connecting to the FDA authorizes marketing of new implant to repair a torn ACL. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. 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. 2016 Oct;44(10):2579-2588. doi: 10.1177/0363546516655333. If the latter holds true in clinical patients, then the impact of the BEAR procedure will be even greater.. During that time, we have observed that younger patients are ready to return to sports at four months, with older patients at six months. A whipstitch of No. Read our. 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. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. Am J Sports Med. D.E.K., L.J.M., and Y.-M.Y. 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). Arthrometry measures the difference in laxity between a person's healthy leg and their injured leg. Conclusion: These include educational payments from Kairos Surgical (D.E.K., Y.-M.Y.) Accessibility 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. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. 2023;9:8. doi: 10.1051/sicotj/2023007. HHS Vulnerability Disclosure, Help 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. The Lifespan Orthopedics Institute is managing the only New England . 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 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. If the repair does fail, it is much easier to fix than when a graft fails, he says. Businesswire. 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. Benefits of BEAR ACL Repair in Pediatric Patients. Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. Why is that an issue? ACL reconstruction surgery has been a staple of modern sports medicine for decades. "Today's marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.". 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. 2020 Feb;44(2):365-380. doi: 10.1007/s00264-019-04417-8. PMID: 24646218. Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . Patients must have an ACL stump attached to the tibia to construct the repair. Although ACL reconstruction is effective, the procedure has drawbacks; the . 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. In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. 2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. 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. 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. Key Takeaways. Copyright Regenexx 2023. How is the BEAR implant different from reconstruction? . Epub 2023 Apr 13. Murray, M, et al. Updated April 2020. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. 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. Br J Sports Med. 2014;42(7):1567-1573. doi:10.1177/0363546514530088. These promising results suggest that longer-term studies of this technique are justified. Y.-M.Y. (A) The torn anterior cruciate ligament (ACL) tissue is preserved. Background: 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]). Its 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. This allows for ACL repair. Unable to load your collection due to an error, Unable to load your delegates due to an error, Stepwise demonstration of the bridge-enhanced anterior cruciate ligament repair (BEAR) technique using the scaffold. 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.

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