M.M.M. Schematic of the technique used to place the BEAR implant. 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 ACL implant isnt a traditional device like those used in most joint repairs. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. It is recommended that the BEAR device be implanted within 50 days of injury. 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. Murray also believes the implant will be a new gold standard for ACL repair in the future. Unable to load your collection due to an error, Unable to load your delegates due to an error. Orthop J Sports Med. This allows for ACL repair. has equity interests in and is a consultant for MIACH Orthopaedics, a company that has licensed the BEAR scaffolding technology from Boston Childrens Hospital, which is also an equity holder in MIACH Orthopaedics; has patents/patents pending for the BEAR technology from Boston Childrens Hospital and Rhode Island Hospital; has received payment for grant review from the Musculoskeletal Transplant Foundation; receives royalties from Springer; and has research grants from the NIH, the Department of Defense, and the NFL Players Association through the Football Players Health Study. FDA authorizes marketing of new implant to repair a torn ACL. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. NOTE: This blog post provides general information to help the reader better understand regenerative medicine, musculoskeletal health, and related subjects. 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. "Today's marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.". (2) Culvenor AG, Eckstein F, Wirth W, Lohmander LS, Frobell R. Loss of patellofemoral cartilage thickness over 5 years following ACL injury depends on the initial treatment strategy: results from the KANON trial. 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. Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? BEAR ACL repair technique shows promise for patients whose injuries are in the subset of ACL tears where the ACL still has some good substance after it is torn. If you have questions or comments about this blog post, please email us at [emailprotected]. 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. Failure rates for anterior cruciate ligament (ACL) repair are greater than those for ACL reconstruction. It doesnt require a second wound site to remove healthy tendon and does not involve donors. Hence, you would need a Regenexx network physician to look at your actual MRI images. 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]). Am J Sports Med. The BEAR Implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). J Orthop Sports Phys Ther. How can you tell which type of complete ACL tear is which? In total, 96% of the patients returned for 2-year follow-up. Irradiated Hamstring Tendon Allograft Versus Autograft for Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction: Midterm Clinical Outcomes. 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. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. (9) Kamien PM, Hydrick JM, Replogle WH, Go LT, Barrett GR. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001). The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. However, whether patients experience a faster psychological recovery after BEAR than traditional ACLR is unknown. 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. 2023;9:8. doi: 10.1051/sicotj/2023007. Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. M.M.M. Tissue Eng Part A. J Transl Med. This site needs JavaScript to work properly. Miach Orthopaedics BEAR implant granted FDA de novo approval for treatment of ACL tears. 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. 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. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. ACL tears can occur at any age and are more frequent in women than men. The bodys own tissue eventually replaces the implant. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. and transmitted securely. effective surgery for ACL tears.17,23 The BEAR technique does not require the compromise of other healthy tissues around the knee, as is required with ACL reconstruction with an autograft. 2015;43:121-127. ACL tears are often treated with surgery called ACL reconstruction. Further work is planned is an assistant editor for The American Journal of Sports Medicine, the spouse of M.M.M. The typical treatment for this injury is reconstructive surgery. Epub 2019 Feb 8. Arthroscopy. 8600 Rockville Pike Lu W, Deng Z, Essien AE, Arthur Vithran DT, Opoku M, Li Y, Xiao W. J Clin Med. So hopefully, well see more ACL repair than tendon grafts in the near future! The BEAR Implant from Miach Orthopaedics was approved by the U.S. Food and Drug Administration in December 2020. 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 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 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. 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. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. 2006;34(1):128135. Federal government websites often end in .gov or .mil. Bookshelf Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. 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. 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 . Am J Sports Med. 90 clinic locations offering non-surgical Regenexx solutions for musculoskeletal pain. 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. 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. Recruitment for the BEAR II trial was initiated in May 2015, and enrollment was completed June 2016. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Media Contact:Abby Capobianco, 240-461-9059Consumer Inquiries: [emailprotected], 888-INFO-FDA. 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. 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). A patient may recover strength faster after a BEAR than traditional ACLR. 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. FDA authorizes marketing of new implant to repair a torn ACL. Epub 2010 Jun 16. Patients were unblinded after their 2-year visit. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. 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. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). eCollection 2023 Apr. Network meta-analysis of knee outcomes following anterior cruciate ligament reconstruction with various types of tendon grafts. 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. 2018 Sep 3;16(1):246. doi: 10.1186/s12967-018-1623-3. Share this article. Scand J Med Sci Sports. 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. 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 less invasive procedure lends itself to faster recovery of muscle strength after surgery and prevents morbidities associated with traditional grafts, such as kneeling pain or hamstring deficits. At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State. Other patients showed higher signal intensity within the graft itself (eg, bottom row [third from left]), reflecting increased fluid within the graft. 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. Accessibility Data on the first patients who got the implant reporting on their six-year post-surgical outcomes is starting to come in, he says. Lets look at the positives and negatives of this new technology and compare it to the Regenexx perc-ACLR procedure. The BEAR Implant is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Meaning these patients return to sports just like those who get ACLR surgery. 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. Updated December 17, 2020. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. J Bone Joint Surg Am. AR065462 and R01AR056834). 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. official website and that any information you provide is encrypted The current technique for bridge-enhanced ACL repair (BEAR) involves placing a resorbable protein-based implant containing autologous blood in the gap between the 2 torn ends of a midsubstance ACL tear in combination with suture repair of the ligament and a suture cinch to reduce the tibiofemoral joint . Orthop J Sports Med. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. Migliorini F, Vecchio G, Eschweiler J, Schneider SM, Hildebrand F, Maffulli N. J Orthop Traumatol. 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. Kristen Fischer is a journalist who has covered health news for more than a decade. 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. "Torn ACLs are among the most common knee injuries in the United States," according to Capt. Given that most reinjuries following BEAR and ACL reconstruction occur within the first year, the long-term results are likely to remain excellent.. *DISCLAIMER: Like all medical procedures, Regenexx Procedures have a success and failure rate. That tendon is secured in the tunnels and now serves as a replacement ligament. 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. Duke . However, given that BEAR is a new technology, most surgeons are unlikely to allow a return to sports at six months. 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. Study design: 2006;34:128-135. Regenexx Perc-ACLR has been performed since 2012. 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. Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. Posterior cruciate ligament repair seems safe with low failure rates but more high level evidence is needed: a systematic review. 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. J Orthop Surg (Hong Kong). Tang C, Kwaees TA, Accadbled F, Turati M, Green DW, Nicolaou N. J Child Orthop. 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. Within about eight weeks of the BEAR Implant surgical procedure, it is absorbed and replaced by the bodys own tissue. 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. Progression of osteoarthritis after double- and single-bundle anterior cruciate ligament reconstruction. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). Epub 2020 Apr 16. 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 . 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. Accessibility 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. 8600 Rockville Pike Clipboard, Search History, and several other advanced features are temporarily unavailable. Today, the U.S. Food and Drug Administration granted marketing authorizationunder the De Novo premarket review pathwayfor an anterior cruciate ligament (ACL) implant . "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. 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). Preserve and heal the . Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. Would you like email updates of new search results? Before sharing sensitive information, make sure you're on a federal government site. 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. These promising results suggest that longer-term studies of this technique are justified. 2023 Mar;51(3):NP12-NP14. 2023 Mar 2;12(5):1999. doi: 10.3390/jcm12051999. 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. These include educational payments from Kairos Surgical (D.E.K., Y.-M.Y.) For full product and risk information . Meaning the cartilage destruction markers after an ACL reconstruction surgery are similar to those seen right after the original injury, causing a double hit to the cartilage. 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. government site. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. 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. 1991;14(3):114120. 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. When a patient tears the Anterior Cruciate Ligament (ACL) in the knee and physical therapy cannot return that individual to sports, ACL reconstruction surgery (ACLR) is usually the next step. Patients must have an ACL stump attached to the tibia to construct the repair. PMID: 30176875; PMCID: PMC6122476. (6) Patterson MR, Delahunt E. A diagonal landing task to assess dynamic postural stability in ACL reconstructed females. All rights reserved. It is a . The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. The BEAR Implant is absorbed by the body as the ACL heals. PMID: 30033738; PMCID: PMC7298591. 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. . Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH Miach Orthopaedics' Bridge-Enhanced ACL Repair (BEAR) Implant has received marketing approval for the treatment of anterior cruciate ligament tears. Raquel Peat, Ph.D., MPH, USPHS, director of the Center for Devices and Radiological Health's Office of Orthopedic Devices. Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. Review article: validity of the KT-1000 knee ligament arthrometer. (12) Wirth W, Eckstein F, Culvenor AG, Hudelmaier MI, Stefan Lohmander L, Frobell RB. 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. Why is that an issue? Published Dec. 17, 2020 Greg Slabodkin Senior Editor Courtesy of Miach Orthopaedics Dive Brief: FDA has authorized a resorbable implant under the De Novo premarket review pathway that fills the gap between the torn ends of a patient's anterior cruciate ligament (ACL), one of the most common knee injuries in the U.S. 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. B.C.F. Am J Sports Med. Registration: Orthopaedic Journal of Sports Medicine. Epub 2019 Dec 19. (17) Centeno CJ, Pitts J, Al-Sayegh H, Freeman MD. April 16, 2020. doi:10.1177/0363546520913532. Before These results were key to receiving FDA clearance for the BEAR implant in December of 2020. Knee Surg Sports Traumatol Arthrosc. The injury does not heal on its own, so ACL reconstruction is the only way to repair it. Find a Surgeon. Its an absorbable implant thats derived from bovine collagena naturally occurring protein present in the connective tissue. An official website of the United States government. 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 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. 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). Schematic of the technique used to place the BEAR implant. What is it? has received educational support and hospitality payments from Kairos Surgical. In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. Schedule an appointment with a BEAR-MOON trial physician and find out if you qualify for the trial. It can also be done via sutures, a medical device used to hold body tissues together. 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. all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology.
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