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. What if the anterior cruciate ligament (ACL) had the ability to repair itself? 2006;34(1):128135. Cision Distribution 888-776-0942 Businesswire. Patients report more satisfaction in terms of pain, symptoms, and readiness. . 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. 2009;17:77-79. Upper left panel:, CONSORT (Consolidated Standards of Reporting, CONSORT (Consolidated Standards of Reporting Trials) diagram detailing patient flow through the study., MeSH December 16, 2020. 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 .gov means its official. Am J Sports Med. It is recommended that the BEAR device be implanted within 50 days of injury. 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. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 absorbed by the body as the ACL heals. 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. How is BEAR different than ACLR surgery? 2016;44(7):16601670. Recovery will take months, and re-tearing is common in active individuals. 2021 Jun;39(6):1281-1288. doi: 10.1002/jor.24783. Patients received physical therapy and were followed for two years. Small tunnels (4 mm) are drilled in the femur and tibia, and a cortical button with two No. Commonly, they occur in a non-contact fashion with an acute twisting of the knee. Posterior cruciate ligament repair seems safe with low failure rates but more high level evidence is needed: a systematic review. Many patients never regain their full level of physical activity, even after the procedure., There are a number of advantages to repairing a ligament instead of replacing it," Murray, who founded Miach Orthopaedics, which manufactures the implant, said in a statement. "That is why, more than 30 years ago, we set out to find a way to help the ligament heal itself.". Martha Murray, MD, an orthopedic surgeon at Boston Childrens Hospital and professor at Harvard Medical School who spearheaded the research, notes that the implantis made of the same proteins found in the normal 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). Epub 2014 Mar 20. PMID: 30176875; PMCID: PMC6122476. (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. 2016 Nov 21;4(11):2325967116672176. doi: 10.1177/2325967116672176. A doctor has to weigh which patients would be an ideal candidate to receive the implant over traditional ACL reconstruction. An erratum has been published: J Bone Joint Surg Am. Recruitment for the BEAR II trial was initiated in May 2015, and enrollment was completed June 2016. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. 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 patient needs to have some tissue intact after the tear for the implant to work. 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. and transmitted securely. 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]). Epub 2019 Feb 8. Updated April 2020. 2 absorbable sutures attached to it is passed through the femoral tunnel and engaged on the proximal femoral cortex. PMC In total, 96% of the patients returned for 2-year follow-up. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. Epub 2023 Apr 13. The BEAR group had a significantly higher mean hamstring muscle strength index than the ACLR group at 2 years (98.2% vs 63.2%; P < .001). Is the BEAR Implant Safe? 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. 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. Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration. Am J Sports Med. Patients must have an ACL stump attached to the tibia to construct the repair. 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. Patients were unblinded after their 2-year visit. Most of these injuries happen to non-professional athletes. Am J Sports Med. 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. 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. 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. 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. 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). 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. 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 . Keywords: 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. Arthrometer testing demonstrated mean side-to-side differences in AP laxity that were similar in the 2 groups at 24 months (BEAR, 1.94 2.08 mm; ACLR, 3.14 2.66 mm). Bridge-Enhanced ACL Repair (BEAR) | Lifespan Please enable it to take advantage of the complete set of features! Orthop J Sports Med. 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. This change to our approach will greatly benefit our patients. 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). Bridge-Enhanced ACL Repair vs ACL Reconstruction Randomized controlled trial; Level of evidence, 1. 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 BEAR Implant is different because it works with . 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. Hypothesis: Dec 16, 2020, 14:53 ET. 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. doi: 10.1177/03635465221144035. 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. New technique for ACL repair taps body's own healing power When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. Tissue Eng Part A. eCollection 2022 Oct. See this image and copyright information in PMC. J Pain Res. ACL reconstruction surgery has been a staple of modern sports medicine for decades. Results: Stepwise demonstration of the bridge-enhanced, Stepwise demonstration of the bridge-enhanced anterior cruciate ligament repair (BEAR) technique using the, Magnetic resonance imaging from the 9 patients in the bridge-enhanced anterior cruciate ligament, Magnetic resonance imaging from the 7 patients in the anterior cruciate ligament reconstruction, MeSH 90 clinic locations offering non-surgical Regenexx solutions for musculoskeletal pain. Injury must have occurred within the last 50 days. What if you could skip the surgery and instead have your Bone Marrow Concentrate (BMC), which contains healing stem cells, injected into your ACL? 2023 Feb;51(2):413-421. doi: 10.1177/03635465221142323. Murray, M, et al. 2016 Sep;32(9):1887-904. doi: 10.1016/j.arthro.2016.03.008. Females Have Earlier Muscle Strength and Functional Recovery After Bridge-Enhanced Anterior Cruciate Ligament Repair. In addition, the retear rate that were about to publish is lower for Perc-ACLR than BEAR, and most of our patients end up with a natural double-bundle repair which is less likely with BEAR. 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. Further work is planned (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. PMID: 30033738; PMCID: PMC7298591. AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year - PubMed Why? 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. For Your Consideration: Bridge Enhanced ACL Restoration (BEAR): Why -, Ageberg E, Roos HP, Silbernagel KG, Thomee R, Roos EM. What is it? Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to 2016 Oct;44(10):2579-2588. doi: 10.1177/0363546516655333. PMID: 32558951. Comparable outcomes seen for bridge-enhanced ACL repair - Healio 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. The Regenexx perc-ACLR procedure should be applied in patients that have a complete ACL tear, but the two ends are still connected. Bethesda, MD 20894, Web Policies Anterior cruciate ligament tears treated with percutaneous injection of autologous bone marrow nucleated cells: a case series. Study design: Review article: validity of the KT-1000 knee ligament arthrometer. Epub 2023 Jan 16. Epub 2023 Apr 13. Miach Orthopaedics' BEAR Implant Granted FDA De Novo Approval for