Using the BEAR implant, no other structures in the body need to be compromised in order to harvest a graft to replace the injured ligament. See this image and copyright information in PMC. 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. Orthop J Sports Med. Recruitment for the BEAR II trial was initiated in May 2015, and enrollment was completed June 2016. ACL reconstruction surgery has been a staple of modern sports medicine for decades. 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). At 24 months, 9 of the 10 BEAR patients and 7 of the 10 ACLR patients completed a study visit. Perhaps the single biggest question from an athlete is, When can I return to play? For ACL surgery, the current recommendations are 1-2 years. AOSSM checks author disclosures against the Open Payments Database (OPD). Am J Sports Med. How can you tell which type of complete ACL tear is which? (A) The torn anterior cruciate ligament (ACL) tissue is preserved. 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. -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. Am J Sports Med. Orthop J Sports Med. That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. Clinical Research Progress of Internal Brace Ligament Augmentation Technique in Knee Ligament Injury Repair and Reconstruction: A Narrative Review. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. AR065462 and R01AR056834). 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. 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). B.C.F. 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. Updated December 16, 2020. The International Knee Documentation Committee Subjective Knee Evaluation Form: normative data. Hypothesis: We hypothesized that patients treated with BEAR would have a noninferior . The data supporting the implant is very encouraging. The device, the Bridge-Enhanced ACL Repair (BEAR) Implant, unlike traditional reconstruction, does not require the use of harvested tendons for ACL . Why? 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. Annually in the United States, as many as 250,000 people suffer an ACL tear [2 . (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 preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. 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 . HHS Vulnerability Disclosure, Help 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. Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for 2022 Oct 31;10(10):23259671221132564. doi: 10.1177/23259671221132564. Irradiated Hamstring Tendon Allograft Versus Autograft for Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction: Midterm Clinical Outcomes. has equity interests in and is a consultant for MIACH Orthopaedics. 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. Patients must have an ACL stump attached to the tibia to construct the repair. Would you like email updates of new search results? official website and that any information you provide is encrypted Find a Surgeon. The BEAR Implant for ACL Tears - Regenexx Age, graft size, and Tegner activity level as predictors of failure in anterior cruciate ligament reconstruction with hamstring autograft. December 16, 2020. 2013 Oct;41(10):2340-6. doi: 10.1177/0363546513498998. The BEAR III trial was designed to evaluate the effects of age on outcomes following the BEAR procedure. M.M.M. 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. The Football Players Health Study is funded by a grant from the National Football League (NFL) Players Association. Accessibility 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. Upper right panel: After a cortical button carrying free sutures (green) is passed up through the femoral tunnel, the BEAR implant is loaded onto them and soaked with up to 10 mL of autologous blood. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. Harvard Health Publishing. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. (15) Centeno C, Lucas M, Stemoer I, Dodson E. IMAGE-GUIDED INJECTION OF ANTERIOR CRUCIATE LIGAMENT TEARS WITH AUTOLOGOUS BONE MARROW CONCENTRATE AND PLATELETS: MIDTERM ANALYSIS FROM A RANDOMIZED CONTROLLED TRIAL. Osteoarthritis Cartilage. 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. -, Akelman MR, Fadale PD, Hulstyn MJ, et al. Would you like email updates of new search results? 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. "Today's marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.". Bookshelf Tissue Eng Part A. Lu W, Deng Z, Essien AE, Arthur Vithran DT, Opoku M, Li Y, Xiao W. J Clin Med. D.E.K., L.J.M., and Y.-M.Y. The .gov means its official.Federal government websites often end in .gov or .mil. Quantitative MRI Biomarkers to Predict Risk of Reinjury Within 2 Years After Bridge-Enhanced ACL Restoration. Results: If the latter holds true in clinical patients, then the impact of the BEAR procedure will be even greater.. 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. 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. That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. Because ACLs do not repair themselves, the surgeon typically uses a tendon graft from another part of the patients body to replace the ACL. 2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. Within eight weeks, the body absorbs the implant and replaces it with new tissue that gets stronger over time. Her work has appeared in outlets like Healthline, Prevention, and HealthDay. In arthrometric assessments, measurements below 3 mm (the height of a stack of two pennies) are considered to be normal. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). 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. PDF Bridge-Enhanced Anterior Cruciate Ligament Repair: The Next Step Epub 2018 Jul 22. 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. The BEAR device must be implanted within 50 days of injury. 2009;17:77-79. 2013 Jun 28;15(3):205-14. doi: 10.5604/15093492.1058410. 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. PMID: 20810079. In the study, 65 patients received the BEAR Implant and 35 members of the control group received ACL reconstruction with autograft (using their own tendon from another part of the body). Epub 2020 Apr 16. (13) Paterno MV, Rauh MJ, Schmitt LC, Ford KR, Hewett TE. The American Journal of Sports Medicine. 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. R01 AR056834/AR/NIAMS NIH HHS/United States, R01 AR065462/AR/NIAMS NIH HHS/United States, Abourezk MN, Ithurburn MP, McNally MP, et al. The Regenexx perc-ACLR procedure should be applied in patients that have a complete ACL tear, but the two ends are still connected. When applied correctly to suitable patients, these two really shouldnt compete head to head in that they are focused on two different types of ACL injuries. James received a Master of Library Science degree from Dominican University. However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. This research was also conducted with support from the Football Players Health Study at Harvard University. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. 2020 Jul;11(3):329-337. doi: 10.1177/1947603518790009. Duke . Background: However, whether patients experience a faster psychological recovery after BEAR than traditional ACLR is unknown. 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. ACL tears are often treated with surgery called ACL reconstruction. Verywell Health's content is for informational and educational purposes only. The site is secure. (12) Wirth W, Eckstein F, Culvenor AG, Hudelmaier MI, Stefan Lohmander L, Frobell RB. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year - PubMed And what does it have to do with my (ouch) torn ACL (anterior cruciate ligament)? How is the BEAR implant different from reconstruction? 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. PDF December 16, 2020 - Food and Drug Administration Failure rates for anterior cruciate ligament (ACL) repair are greater than those for ACL reconstruction. Assessment of neuromuscular control in patients after anterior cruciate ligament reconstruction. Am J Sports Med. The Most Comprehensive Orthopedic Care in the Region, Orthopedic Surgeons and Specialists in Rhode Island, Meet Our Team - Shoulder and Elbow Specialists, As Orthopedic Patients Get Younger, Procedures Get More Advanced, Meet Our Team - Sports Medicine Specialists, Meet Our Team - Orthopedic Trauma Specialists, Research Breaks Through to the Other Side of the Blood Brain Barrier, Cerebral Palsy: Enhancing Functional Recovery, ACL Research: A Q&A with Braden Fleming, PhD, Predicting Thumb Carpometacarpal Osteoarthritis, Pursuing the Promise of Smart Joint Implants, Women's Lacrosse Focus of Lifespan Bioengineering Researcher, Surgeons Persistence, Prowess Saves Fishermans Hand, Cartilage Transplant Returns Brittney to Athletic Activity, Research and Clinical Trials at the Lifespan Orthopedics Institute, Have suffered a complete ACL tear (as documented on an MRI scan by a medical professional) within the past 50 days, Were advised by a medical professional that surgery is recommended to treat the ACL tear, Are willing to follow the study instructions for return visits and rehabilitation exercises. J Transl Med. FDA authorizes marketing of new implant to repair a torn ACL. Further work is planned Murray MM, Kalish LA, Fleming BC; BEAR Trial Team; Flutie B, Freiberger C, Henderson RN, Perrone GS, Thurber LG, Proffen BL, Ecklund K, Kramer DE, Yen YM, Micheli LJ. Am J Sports Med. 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. Patients must have an ACL stump attached to the tibia to construct the repair. 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. U.S. Food and Drug Administration. Knee Surg Sports Traumatol Arthrosc. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group (P = .0001). An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months; no patients in either group had C (abnormal) or D (severely abnormal) grades. all have disclosures as listed in the American Academy of Orthopaedic Surgeons database, none of which are related to this current project or technology. 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. The BEAR Implant was granted De Novo Approval from the U.S. Food and Drug Administration in December 2020. 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. Background: Why is that an issue? More information about this clinical trial and the BEAR ACL restoration procedure is available at www.bearmoon.org. Orthop J Sports Med. BEAR and the Regenexx Perc-ACLR procedure are better than an ACLR surgery in many ways. 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. 2018;26:1362-1366. FOIA Bridge-enhanced Anterior Cruciate Ligament Repair (BEAR) Implant As the intra-articular environment is complex in its response to implanted materials, this study was designed to determine whether there . Lower right panel: The sutures and extracortical buttons are secured. It is recommended that the BEAR device be implanted within 50 days of injury. Benefits of BEAR ACL Repair in Pediatric Patients. 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 intact fibers have low signal intensity (black), reflecting highly organized tissue with little free water. Hip Avascular Necrosis | Preservation & Replacement FOIA 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. 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. is a founder, paid consultant, and equity holder in Miach Orthopaedics, Inc, which was formed to work on upscaling production of the BEAR scaffold. Measurements below 3 millimeters (mm) are considered normal. 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 . "Torn ACLs are among the most common knee injuries in the United States," according to Capt. Epub 2023 Apr 13. sharing sensitive information, make sure youre on a federal also has received multiple payments for food and beverage from various companies. BEAR: An Innovative Solution for an ACL Tear Given that most reinjuries following BEAR and ACL reconstruction occur within the first year, the long-term results are likely to remain excellent.. Bridge-Enhanced ACL Repair (BEAR) Allows Torn ACL to Heal Itself Bridge Enhanced ACL Restoration (BEAR Implant) 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. Epub 2010 Jun 16. 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. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. The BEAR Implant from Miach Orthopaedics was approved by the U.S. Food and Drug Administration in December 2020. Mansour J, Ghanimeh J, Ghoul A, Estephan M, Khoury A, Daher M. SICOT J. 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]). 2017;45(1):97105. (6) Patterson MR, Delahunt E. A diagonal landing task to assess dynamic postural stability in ACL reconstructed females. PMID: 30033738; PMCID: PMC7298591. -. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. In this small, first-in-human study, BEAR produced similar outcomes to ACLR with a hamstring autograft. eCollection 2023 Apr. The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. James Lacy, MLS, is a fact-checker and researcher. "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. 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. Recovery will take months, and re-tearing is common in active individuals. Dec 16, 2020, 14:53 ET. The BEAR Implant was cleared by the U.S. Food & Drug Administration through the De Novo Pathway. 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. BEAR Implant | ACL Restoration | Miach Orthopaedics 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 patients were also measured using an arthrometer, which measures the range of movement in a joint. Keywords: Surgical techniques in the management of pediatric anterior cruciate ligament tears: Current concepts. 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. 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. It is a . The Lifespan Orthopedics Institute is managing the only New England . 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). 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. Cision Distribution 888-776-0942 In the study, 65 patients received the BEAR Implant and 35 members of the control group received ACL reconstruction with autograft (using their own tendon from another part of the body). Dr. Fleming: ACL reconstruction surgery in active patients has been the gold standard treatment for more than three decades. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. Am J Sports Med. Purpose/hypothesis: The purpose of this study was to report the 12- and 24-month outcomes of patients who . 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. 33,34 The scaffold is used to bridge the . 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. 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. 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. During that time, we have observed that younger patients are ready to return to sports at four months, with older patients at six months. 2006;34(1):128135. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. (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. 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. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. 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. A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Her discoveries led to the conceptualization of an implant that could be placed between the torn ends of the ACL to bridge the gap, which is then mixed with the patients own blood to stimulate healing. Cartilage. Likely lowered prevalence of early arthritis and tearing the opposite ACL as the normal biomechanics of the knee are preserved. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). -, Ageberg E, Roos HP, Silbernagel KG, Thomee R, Roos EM. The https:// ensures that you are connecting to the Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes.
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