Businesswire. from 8 AM - 9 PM ET. PDF December 16, 2020 - Food and Drug Administration Dr. Fadale: ACL tears are among the most common knee injuries. -. Harvard Health Publishing. Orthop J Sports Med. Arthrometry measures the difference in laxity between a persons healthy leg and their injured leg. Osteoarthritis Cartilage. PMID: 20810079. 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. Background: While a sex effect on outcomes following anterior cruciate ligament (ACL) reconstruction surgery has been previously documented, less is known following bridge-enhanced ACL repair (BEAR). 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. 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. Am J Sports Med. 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. Despite minor improvements to the procedure, clinical outcomes have not really changed. Epub 2023 Jan 13. Am J Sports Med. The peripheral higher signal intensity (lighter gray) indicates increased higher water content in the tissues surrounding the repaired ACL. How is BEAR different than ACLR surgery? A small percentage of patients treated with the BEAR Implant re-tore their ACL when they returned to sports sooner than recommended and then had a standard ACL reconstruction. 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. ACL reconstruction; ACL repair; BEAR; anterior cruciate ligament; bridge-enhanced ACL repair; human. Incidence of Second ACL Injuries 2 Years After Primary ACL Reconstruction and Return to Sport. 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). The BEAR device must be implanted within 50 days of injury. Br J Sports Med. Patients report more satisfaction in terms of pain, symptoms, and readiness. Why is that an issue? Psychological Readiness to Return to Sport at 6 Months Is Higher After Bridge-Enhanced ACL Restoration Than Autograft ACL Reconstruction: Results of a Prospective Randomized Clinical Trial. Irradiated Hamstring Tendon Allograft Versus Autograft for Anatomic Double-Bundle Anterior Cruciate Ligament Reconstruction: Midterm Clinical Outcomes. April 16, 2020. doi:10.1177/0363546520913532. 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. ACL injuries are among the most common knee injuries and affect around 400,000 Americans each year. Murray also believes the implant will be a new gold standard for ACL repair in the future. Comparable Instrumented Knee Joint Laxity and Patient-Reported Outcomes After ACL Repair: Response. The FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. Because ACLs do not repair themselves, the surgeon typically uses a tendon graft from another part of the patients body to replace the ACL. 2019 Mar 22;7(3):2325967118824356. doi: 10.1177/2325967118824356. Before PMID: 23959965. The upshot? FDA Authorizes Marketing of New Implant to Repair a Torn ACL 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 . Hypothesis: with the inherently same conflicts. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. What if the anterior cruciate ligament (ACL) had the ability to repair itself? Bridge-Enhanced ACL Repair (BEAR) Allows Torn ACL to Heal Itself AR065462 and R01AR056834). -, Anderson AF, Irrgang JJ, Kocher MS, Mann BJ, Harrast JJ; International Knee Documentation Committee. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. 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. Propensity for Clinically Meaningful Improvement and Surgical Failure After Anterior Cruciate Ligament Repair. It's a multi-center, randomized, clinical trial seeking adult participants with a torn ACL that has occurred within the past 50 days, who qualify for surgery . When typing in this field, a list of search results will appear and be automatically updated as you type. Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. This new technique provides promise that soon surgeons will be able to repair and regenerate the ACL instead of replacing it. 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. An official website of the United States government. Hamstring strength asymmetry at 3 years after anterior cruciate ligament reconstruction alters knee mechanics during gait and jogging. Am J Sports Med. These are: The acronym BEAR stands for Bridge Enhanced ACL Repair. 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. 2006;34(1):128135. To make that happen, the doctor precisely seeds your damaged ACL with BMC using x-ray guidance (fluoroscopy). PMID: 30737199. 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 patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. Trends in Anterior Cruciate Ligament Repair: A Bibliometric and Visualized Analysis. sharing sensitive information, make sure youre on a federal That would be a shame, as its exposing the patient to more risk than is required to get good clinical results. Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH J Exp Orthop. Registration: 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. 2013 Dec;20(6):532-6. doi: 10.1016/j.knee.2013.07.008. 2023;9:8. doi: 10.1051/sicotj/2023007. Finally, returning to play is likely much quicker for a precise image-guided injection than the BEAR surgery. The .gov means its official. (A) The torn anterior cruciate ligament (ACL) tissue is preserved. Patients were unblinded after their 2-year visit. BEAR-MOON is an acronym for BEAR (Bridge-Enhanced ACL Restoration) MOON (Multicenter Orthopaedic Outcomes Network). These promising results suggest that longer-term studies of this technique are justified. (6) Patterson MR, Delahunt E. A diagonal landing task to assess dynamic postural stability in ACL reconstructed females. 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. 8600 Rockville Pike HHS Vulnerability Disclosure, Help has received educational support and hospitality payments from Kairos Surgical. doi: 10.1177/03635465221144035. Bridge-enhanced ACL repair (BEAR) is a new FDA-approved procedure that allows a torn ACL to heal itself and does not require graft tissue to be taken from another part of the body. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. Media Contact:Abby Capobianco, 240-461-9059Consumer Inquiries: [emailprotected], 888-INFO-FDA. 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. Orthopaedic Journal of Sports Medicine. Our website is not intended to be a substitute for professional medical advice, diagnosis, or treatment. The ACL, a ligament located with the knee, is the tissue responsible for bridging the shinbone to the thigh bone. 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. 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. Systemic Review of Anatomic Single- Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Does Femoral Tunnel Drilling Technique Matter? Recruitment for the BEAR MOON trial was initiated in September of 2021 and the study is currently underway. Cartilage. NCT02664545 (ClinicalTrials.gov identifier). February 2022. doi:10.1177/23259671211070542. and transmitted securely. Complications observed in the study consisted of graft or repair failure and the need for additional surgical procedures. How can you tell which type of complete ACL tear is which? Do you have a torn ACL? 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. 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. eCollection 2023 Apr. This change to our approach will greatly benefit our patients. Bethesda, MD 20894, Web Policies 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. 2023 Apr 26;10(1):49. doi: 10.1186/s40634-023-00605-z. -, Ageberg E, Roos HP, Silbernagel KG, Thomee R, Roos EM. National Library of Medicine AOSSM checks author disclosures against the Open Payments Database (OPD). Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. BEAR Implant | ACL Restoration | Miach Orthopaedics AOSSM checks author disclosures against the Open Payments Database (OPD). BEAR ACL Repair Technique | Knee Surgeon | Minnesota 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. Bridge-enhanced Anterior Cruciate Ligament Repair (BEAR) Implant The patients were also measured using an arthrometer, which measures the range of movement in a joint. 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. All rights reserved. The FDA granted the marketing authorization to Miach Orthopaedics, Inc. 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. Results: Am J Sports Med. When Does a Partial ACL Tear Require Surgery? Knee Surg Sports Traumatol Arthrosc. 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. 2023 Feb 20;24(1):8. doi: 10.1186/s10195-023-00688-5. 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. James received a Master of Library Science degree from Dominican University. Federal government websites often end in .gov or .mil. 2023 Apr 12;11(4):23259671221146815. doi: 10.1177/23259671221146815. eCollection 2022 Oct. See this image and copyright information in PMC. 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. The results were excellent (more on those below). (From Murray et al.). 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. 2016 Oct;44(10):2579-2588. doi: 10.1177/0363546516655333. 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. In a recently published Randomized Controlled Trial (RCT), the BEAR procedure was shown to be as good or better than ACL reconstruction surgery (1). 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. However, I am concerned that orthopedic surgeons may begin to take full-thickness non-retracted tears and shove those inappropriately into the BEAR category. By Kristen Fischer PMC Before sharing sensitive information, make sure you're on a federal government site. The BEAR procedure is a promising technique that will likely meet these goals. Please enable it to take advantage of the complete set of features! Accessibility At two years, control subjects had a laxity that, on average, was greater by 1.8 mm in the treated knee than that of the untreated knee. Recovery will take months, and re-tearing is common in active individuals. Tang C, Kwaees TA, Accadbled F, Turati M, Green DW, Nicolaou N. J Child Orthop. Whether it replaces ACL reconstruction as the gold standard remains to be seen but I am optimistic it will, Fleming adds. The ACL implant isnt a traditional device like those used in most joint repairs. 2019 Sep;53(18):1168-1173. doi: 10.1136/bjsports-2018-100167. PMID: 23962647. New technique for ACL repair taps body's own healing power 2023 Mar;51(3):NP12-NP14. 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. It is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. How is the BEAR implant different from reconstruction? Comparable outcomes seen for bridge-enhanced ACL repair - Healio 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. Glasbrenner J, Raschke MJ, Kittl C, Herbst E, Peez C, Briese T, Michel P, Herbort M, Ksters C, Schliemann B. On June 4, 2020, FDA received your De Novo requesting classification of the BEAR (Bridge-Enhanced ACL Repair) Implant. The site is secure. Patients must have an ACL stump attached to the tibia to construct the repair. 2 absorbable suture (purple) is placed into the tibial stump of the ACL. (8) Nyland J, Klein S, Caborn DN. 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. There were no graft or repair failures in the first 24 months after surgery. PMC 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). Am J Sports Med. 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). 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. 2020 Jul;26(13-14):702-711. doi: 10.1089/ten.tea.2020.0057. Methods: 8600 Rockville Pike It doesnt require a second wound site to remove healthy tendon and does not involve donors.
Amtrak Locomotive Roster, Articles B