For the BEAR Trial Team, B.P. 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. Magnetic resonance imaging from the 7 patients in the anterior cruciate ligament reconstruction (ACLR) group at 24 months shows an intact graft between the femoral and tibial tunnels (arrows). When Does a Partial ACL Tear Require Surgery? 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. Thus, there remains a need to find a new method that is less invasive and has the potential to provide better outcomes. 2 absorbable suture (purple) is placed into the tibial stump of the ACL. The FDA granted marketing authorization for an implant to repair the injury. The Bridge-Enhanced ACL Repair (BEAR) Implant is an alternative to ACL reconstruction, which typically requires harvesting tendonsand sometimes bonefrom another part of the patients body or a deceased donor. sharing sensitive information, make sure youre on a federal eCollection 2023 Apr. Results: 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. It is recommended that the BEAR device be implanted within 50 days of injury. 90 clinic locations offering non-surgical Regenexx solutions for musculoskeletal pain. (13) Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. The data supporting the implant is very encouraging. PMID: 30176875; PMCID: PMC6122476. 2017;45:97-105. Patients with the implant had an average that was greater by 1.61 mm in the treated knee compared to their untreated knee. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the bodys own tissue. 2015;43:121-127. Historically, the repair method of just suturing the two ends together has not been very effective.". Tissue Eng Part A. (4) King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. The relationships among isometric, isotonic, and isokinetic concentric and eccentric quadriceps and hamstring force and three components of athletic performance. The .gov means its official. However, whether patients experience a faster psychological recovery after BEAR than traditional ACLR is unknown. Dont wait. The request was submitted under section 513(f)(2) of the FD&C Act. -. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. 2010 Sep;26(9):1212-25. doi: 10.1016/j.arthro.2010.01.003. 2020 08:00 AM Eastern Standard Time. Patients received physical therapy and were followed for two years. 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). These patients are currently being followed to determine long term outcomes. 2021 Feb 3;103 (3):e14. The bodys own tissue eventually replaces the implant. The BEAR Implant was cleared by the U.S. Food & Drug Administration through the De Novo Pathway. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. 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. ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. 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. also has received multiple payments for food and beverage from various companies. official website and that any information you provide is encrypted Epub 2023 Jan 16. For full product and risk information . 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. 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. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. The most significant differences are that BEAR still requires surgery, and the Regenexx Perc-ACLR procedure is a precise image-guided injection. Its not something that every patient will be eligible for, Alan Getgood, MD, an orthopedic surgeon specializing in knee reconstruction at the Fowler Kennedy Sport Medicine Clinic in Canada, tells Verywell. The .gov means its official.Federal government websites often end in .gov or .mil. Dec 16, 2020, 14:53 ET. Murray points out that patients who incurred an ACL months ago or who have little ACL tissue left would be more likely to benefit from an ACL reconstruction, rather than this implant. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. 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. Am J Sports Med. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). Review article: validity of the KT-1000 knee ligament arthrometer. PMID: 23959965. 2006;34(1):128135. government site. PMID: 20810079. Murray, M, et al. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the body's own tissue. Results: 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. Osteoarthritis Cartilage. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Methods: 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). This research was also conducted with support from the Football Players Health Study at Harvard University. 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. Epub 2020 Apr 16. M.M.M. Epub 2013 Aug 19. (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. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. Unable to load your collection due to an error, Unable to load your delegates due to an error. Lower right panel: The sutures and extracortical buttons are secured. And what does it have to do with my (ouch) torn ACL (anterior cruciate ligament)? The BEAR III trial was designed to evaluate the effects of age on outcomes following the BEAR procedure. About Miach Orthopaedics, Inc. Other patients showed higher signal intensity within the graft itself (eg, bottom row [third from left]), reflecting increased fluid within the graft. The https:// ensures that you are connecting to the B.C.F. Incidence of Second ACL Injuries 2 Years After Primary ACL Reconstruction and Return to Sport. 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. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. 2021 Jun;39(6):1281-1288. doi: 10.1002/jor.24783. Find a Surgeon. 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). Recruitment for the BEAR MOON trial was initiated in September of 2021 and the study is currently underway. The BEAR Implant is available in select cities across the U.S. Dr. David Johannesmeyer is the first sports medicine surgeon to perform a BEAR Implant ACL Repair. Am J Sports Med. 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. 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. FOIA Keywords: Randomized controlled trial; Level of evidence, 1. (11) Barenius B, Ponzer S, Shalabi A, Bujak R, Norln L, Eriksson K. Increased risk of osteoarthritis after anterior cruciate ligament reconstruction: a 14-year follow-up study of a randomized controlled trial. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. 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. Disclaimer. Share this article. maintained a conflict-of-interest management plan that was approved by Boston Childrens Hospital and Harvard Medical School during the conduct of the trial, with oversight by both conflict-of-interest committees and the institutional review board of Boston Childrens Hospital, as well as the US Food and Drug Administration. If those that undergo the BEAR procedure return to sports faster and have lower rates of re-injury and osteoarthritis, it is definitely possible that it could become the new gold standard.. Accessibility The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. Verywell Health's content is for informational and educational purposes only. PMID: 23897997. A whipstitch of No. Disclaimer. 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. 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. The peripheral higher signal intensity (lighter gray) indicates increased higher water content in the tissues surrounding the repaired ACL. The site is secure. 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. (8) Nyland J, Klein S, Caborn DN. 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. On the other hand, those in the control group had a laxity in the treated knee of 1.77 mm. Updated December 16, 2020. 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). 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. Epub 2023 Apr 13. 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). 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). Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. ________________________________________________________________. If you have questions or comments about this blog post, please email us at [emailprotected]. A piece of hamstring or quadriceps tendon is harvested, and then graft tunnels are drilled into the femur and tibia. Trends in Anterior Cruciate Ligament Repair: A Bibliometric and Visualized Analysis. BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. 2016 Oct;44(10):2579-2588. doi: 10.1177/0363546516655333. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. In my experience, about 1/3 of all complete ACL tears are retracted (BEAR candidate), and about 2/3rds are non-retracted (Regenexx Perc-ACLR candidate). Epub 2020 Jun 25. 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 . Fleming says the FDA approval was exciting news that provides a treatment alternative to ACL reconstruction that does not require removing the injured ligament and replacing it with a graft of tendon.. When typing in this field, a list of search results will appear and be automatically updated as you type. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Healths Office of Orthopedic Devices, Todays marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.. Am J Sports Med. Background: 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. Schematic of the technique used to place the BEAR implant. Failure rates for anterior cruciate ligament (ACL) repair are greater than those for ACL reconstruction. The surgery, however, is not without its problems. Tissue Eng Part A. Irradiated Hamstring Tendon Allograft Versus Autograft for Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction: Midterm Clinical Outcomes. 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. Likely lowered prevalence of early arthritis and tearing the opposite ACL as the normal biomechanics of the knee are preserved. ACL tears are often treated with surgery called ACL reconstruction. -, Arneja S, Leith J. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. Clipboard, Search History, and several other advanced features are temporarily unavailable. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. doi: 10.1177/03635465221144035. 2013 Jun 28;15(3):205-14. doi: 10.5604/15093492.1058410. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. We think you need to have sufficient ACL tissue left to repair for the surgery with the implant to work, Murray says. 2023 Dotdash Media, Inc. All rights reserved, Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. An official website of the United States government. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. 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. Accessibility Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. Home Blog The BEAR Implant for ACL Tears. The patients were also measured using an arthrometer, which measures the range of movement in a joint. Hence, any implant procedure requiring tunnels to be drilled will likely harm cartilage. 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 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. This quicker return to play likely represents a less severe tear type for Perc-ACLR and the use of more powerful bone marrow concentrate versus whole blood for BEAR. The nonabsorbable sutures are threaded through the BEAR scaffold and tibial tunnel and secured in place with an extracortical button. Unauthorized use of these marks is strictly prohibited. (From Murray et al.). 2016;44(7):16601670. (A) The torn anterior cruciate ligament (ACL) tissue is preserved. 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. The International Knee Documentation Committee subjective knee evaluation form: normative data. PMID: 32298131; PMCID: PMC7227128. M.M.M. official website and that any information you provide is encrypted No surgery, drilling, or graft tunnels are required. all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. government site. 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 . It bridges the gap between the torn ends of a patients ACL, and the body then absorbs the implant within about eight weeks of surgery. Zhang Y, Xu C, Dong S, Shen P, Su W, Zhao J. Arthroscopy. Epub 2010 Jun 16. 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. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. Orthop J Sports Med.
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