The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Media Contact:Abby Capobianco, 240-461-9059Consumer Inquiries: [emailprotected], 888-INFO-FDA. 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. Am J Sports Med. 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. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human. M.M.M. The BEAR Implant was cleared by the U.S. Food & Drug Administration through the De Novo Pathway. Patients must have an ACL stump attached to the tibia to construct the repair. 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. Epub 2020 Apr 16. Injury must have occurred within the last 50 days. During that time, we have observed that younger patients are ready to return to sports at four months, with older patients at six months. 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. 1991;14(3):114120. SILVER SPRING, Md., Dec. 16, 2020 /PRNewswire/ --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. Am J Sports Med. Recruitment for the BEAR II trial was initiated in May 2015, and enrollment was completed June 2016. Study design: Disclaimer. Third, while it's unknown if knees repaired with BEAR retain their position sense, that's much more likely than the tendon graft . (4) King JD, Rowland G, Villasante Tezanos AG, Warwick J, Kraus VB, Lattermann C, Jacobs CA. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). A whipstitch of No. has patents/patents pending for the BEAR technology from Boston Childrens Hospital and Rhode Island Hospital, is a paid associate editor for The American Journal of Sports Medicine, has received royalties from Springer, and has received research grants from the NIH and the Department of Defense. ACL injuries are among the most common knee injuries and affect around 400,000 Americans each year. If you have questions or comments about this blog post, please email us at [emailprotected]. The bodys own tissue eventually replaces the implant. The results were excellent (more on those below). Epub 2014 Mar 20. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. Patients must have an ACL stump attached to the tibia to construct the repair. The .gov means its official.Federal government websites often end in .gov or .mil. 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). Would you like email updates of new search results? Before sharing sensitive information, make sure you're on a federal government site. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. Historically, the repair method of just suturing the two ends together has not been very effective.". Epub 2018 Jul 22. 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). At the same time point, the Regenexx Perc-ACLR procedure had an 8% surgery rate, which more similar to the 6% conversion to a second surgery after ACLR surgery reported in the BEAR study. Patients report more satisfaction in terms of pain, symptoms, and readiness. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the bodys own tissue. 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. Propensity for Clinically Meaningful Improvement and Surgical Failure After Anterior Cruciate Ligament Repair. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. If you've torn your ACL and are interested in the new implant, you should talk to your doctors to see if you are a strong candidate for the new procedure or would be better off with an ACL reconstruction. 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. The peripheral higher signal intensity (lighter gray) indicates increased higher water content in the tissues surrounding the repaired ACL. L.J.M. 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. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. The typical treatment for this injury is reconstructive surgery. 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. PMID: 23959965. This provides a healing environment for the torn ACL fibers to repair themselves together, thereby eliminating the need to harvest any tissue for a graft. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Review article: validity of the KT-1000 knee ligament arthrometer. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. B.C.F. 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. Yang XG, Wang F, He X, Feng JT, Hu YC, Zhang H, Yang L, Hua K. Int Orthop. Tissue Eng Part A. from 8 AM - 9 PM ET. Cision Distribution 888-776-0942 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. In Complete ACL Tears, Bridge-Enhanced ACL Repair Was Noninferior to ACL Reconstruction for Symptoms and Functioning and Knee Laxity at 2 Years. The intact fibers have low signal intensity (black), reflecting highly organized tissue with little free water. 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). 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. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. Epub 2016 May 13. Murray, M, et al. 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. 2021 Feb 17;103(4):358. doi: 10.2106/JBJS.20.02088. (From Murray et al.). No surgery, drilling, or graft tunnels are required. BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. 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 . 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. Epub 2020 Jun 25. The gold standard of ACL rupture is using a graft of tendon to replace the ACL, Fleming explains. The recent trial results showed that 14% of patients required ACLR surgery despite the BEAR surgery (1). 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. What if the anterior cruciate ligament (ACL) had the ability to repair itself? Verywell Health's content is for informational and educational purposes only. 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. Epub 2019 Dec 19. When Does a Partial ACL Tear Require Surgery? government site. December 16, 2020. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. Kristen Fischer is a journalist who has covered health news for more than a decade. (A) The torn anterior cruciate ligament (ACL) tissue is preserved. Migliorini F, Vecchio G, Eschweiler J, Schneider SM, Hildebrand F, Maffulli N. J Orthop Traumatol. Murray also believes the implant will be a new gold standard for ACL repair in the future. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. Background: This study assessed the safety of the newly developed bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR), which involves suture repair of the ligament combined with a bioactive scaffold to bridge the gap between the torn ligament ends. 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. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the body's own tissue. We think you need to have sufficient ACL tissue left to repair for the surgery with the implant to work, Murray says. 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. 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 FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. 2017;45(1):97105. BEAR-MOON? Lets look at the positives and negatives of this new technology and compare it to the Regenexx perc-ACLR procedure. 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. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. Bethesda, MD 20894, Web Policies The Bridge-Enhanced ACL Repair (BEAR) Implant is promoted as an alternative to reconstructive surgery using tendons from a patient's body or a tissue bank. -, Anderson MA, Gieck JH, Perrin DH, Weltman A, Rutt RA, Denegar CR. April 16, 2020. doi:10.1177/0363546520913532. Age, graft size, and Tegner activity level as predictors of failure in anterior cruciate ligament reconstruction with hamstring autograft. If the latter holds true in clinical patients, then the impact of the BEAR procedure will be even greater.. 2016;44(7):16601670. Please enable it to take advantage of the complete set of features! 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. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. 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 injury does not heal on its own, so ACL reconstruction is the only way to repair it. Harvard Health Publishing. government site. has equity interests in and is a consultant for MIACH Orthopaedics. What is it? ________________________________________________________________. and food, beverage, and travell reimbursements from 5 companies (each <$500). Recovery will take months, and re-tearing is common in active individuals. This is a bovine collagen implant inserted in the torn area of the ACL with sutures placed in graft tunnels. This concept led to the development of the Bridge-Enhanced ACL Restoration (BEAR) Implant, a fundamental change in the approach to treating ACL injuries. (D) The ends of the torn ACL then grow into the scaffold, which is gradually replaced by healing ligament tissue. "We are working hard to determine if there are specific factors that would identify patients who would be ideal candidates, Fleming says. Cartilage. PMID: 23962647. Dont wait. Patients who had a bridge-enhanced ACL repair technique showed similar patient-report outcomes with no infection or rejection compared with patients who had autograft ACL reconstruction, according . 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). 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. Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. February 2022. doi:10.1177/23259671211070542. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. Epub 2010 Jun 16. Hence, any implant procedure requiring tunnels to be drilled will likely harm cartilage. Epub 2016 Jul 27. 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. Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. Surgical techniques in the management of pediatric anterior cruciate ligament tears: Current concepts. The surgery, however, is not without its problems. Is the BEAR Implant Safe? 2023 Mar;51(3):NP12-NP14. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. Only a single bundle repair of a double bundle ligament means the knee is left rotationally less stable (10), The graft tendon goes in at a steeper angle than the original ACL; hence its more likely to shear and fail (9), No working position sensors in the tendon repair of a ligament mean less position sense (6-8), High likelihood of developing arthritis/doesnt prevent arthritis (11,12), Higher chance of tearing the ACL on the other knee (13), The hamstrings or quadriceps muscles become weaker due to the graft harvest (14), A much less invasive procedure than surgery. How many patients fail the BEAR implant and still need ACL reconstruction surgery? Epub 2013 Aug 18. 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. Additional stitching holds the device in place. The BEAR procedure is a new and different way of thinking about the surgical approach to treating ACL injuries. 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 . 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. That tendon is secured in the tunnels and now serves as a replacement ligament. Thats the Regenexx Perc-ACLR procedure (Percutaneous ACL Repair). Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. J Exp Orthop. Bethesda, MD 20894, Web Policies 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 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. 2021 Jun;39(6):1281-1288. doi: 10.1002/jor.24783. Clipboard, Search History, and several other advanced features are temporarily unavailable. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. 8600 Rockville Pike The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. Tang C, Kwaees TA, Accadbled F, Turati M, Green DW, Nicolaou N. J Child Orthop. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. is an assistant editor for The American Journal of Sports Medicine, the spouse of M.M.M. eCollection 2019 Mar. 2 absorbable suture (purple) is placed into the tibial stump of the ACL. 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]). An official website of the United States government. 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. This site needs JavaScript to work properly. 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. The Football Players Health Study is funded by a grant from the National Football League (NFL) Players Association. ACL reconstruction surgery has been a staple of modern sports medicine for decades. 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. Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. 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. Disclaimer. Epub 2023 Apr 13. Hence, you would need a Regenexx network physician to look at your actual MRI images. The site is secure. (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. 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). Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. Federal government websites often end in .gov or .mil. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. (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. James received a Master of Library Science degree from Dominican University. Finally, returning to play is likely much quicker for a precise image-guided injection than the BEAR surgery. 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. (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. 2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. 2023 Mar 2;12(5):1999. doi: 10.3390/jcm12051999. The most significant differences are that BEAR still requires surgery, and the Regenexx Perc-ACLR procedure is a precise image-guided injection. Patients received physical therapy and were followed for two years. B.C.F. The ACL, a ligament stretching from the front to the back of the knee, aids in keeping the knee stable. Am J Sports Med. PMID: 32298131; PMCID: PMC7227128. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. Because ACLs do not repair themselves, the surgeon typically uses a tendon graft from another part of the patients body to replace the ACL. The Lifespan Orthopedics Institute is managing the only New England . The BEAR-MOON trial is enrolling 200 English-speaking individuals nationwide who: Our team of board-certified orthopedic sports medicine surgeons and researchers specializes in arthroscopic repair of sports-related injuries including complex knee reconstructions. J Orthop Res. 2023 Feb 20;24(1):8. doi: 10.1186/s10195-023-00688-5. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. The BEAR implant goes into single graft tunnels drilled into the femur and tibia like ACLR surgery. Rhode Island Hospital is one of six U.S. hospitals conducting the BEAR-MOON trial that compares outcomes of patients receiving the BEAR implant to those receiving ACL reconstruction. Likely lowered prevalence of early arthritis and tearing the opposite ACL as the normal biomechanics of the knee are preserved. Vandenrijt J, Callenaere S, Van der Auwera D, Michielsen J, Van Dyck P, Heusdens CHW. 2006;34:128-135. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. Bookshelf Functional hop testing results were similar in the 2 groups at 12 and 24 months after surgery. 2020 Feb;44(2):365-380. doi: 10.1007/s00264-019-04417-8. Am J Sports Med. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Given that most reinjuries following BEAR and ACL reconstruction occur within the first year, the long-term results are likely to remain excellent.. 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. 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. 8600 Rockville Pike Kristen Fischer is a journalist who has covered health news for more than a decade. Methods: What if you could skip the surgery and instead have your Bone Marrow Concentrate (BMC), which contains healing stem cells, injected into your ACL? Accessibility These are: The acronym BEAR stands for Bridge Enhanced ACL Repair. In order to classify the BEAR (Bridge-Enhanced ACL Repair) Implant into class I or II, it is necessary that the Knee. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. 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. Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. This allows for ACL repair. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. Failure rates for anterior cruciate ligament (ACL) repair are greater than those for ACL reconstruction. 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. 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. In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. (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. Recruitment for the BEAR MOON trial was initiated in September of 2021 and the study is currently underway. Meaning these patients return to sports just like those who get ACLR surgery. 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 . 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). That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. Am J Sports Med. 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). Am J Sports Med. 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. Unauthorized use of these marks is strictly prohibited. Epub 2020 Apr 16. 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 . 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. For full product and risk information . The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. . 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). military surplus catalogs request, cleveland middle school football roster,
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