Raquel Peat PhD [1]. This double-bundle design ensures that the ACL can control the rotation of the tibia, an essential function in protecting the knee. Epub 2023 Jan 13. (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. This new technique provides promise that soon surgeons will be able to repair and regenerate the ACL instead of replacing it. 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. PDF Bridge-Enhanced Anterior Cruciate Ligament Repair: The Next Step Additional stitching holds the device in place. Conclusion: Duke . Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. "This is very novel. Methods: Dont wait. Am J Sports Med. 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. PMID: 33549723. Small tunnels (4 mm) are drilled in the femur and tibia, and a cortical button with two No. That tendon is secured in the tunnels and now serves as a replacement ligament. 2021 Feb 17;103(4):358. doi: 10.2106/JBJS.20.02088. Ten patients underwent BEAR, and 10 underwent ACLR with a 4-stranded hamstring autograft. 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. 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 . Comparable outcomes seen for bridge-enhanced ACL repair - Healio 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. is an assistant editor for The American Journal of Sports Medicine, the spouse of M.M.M. 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. These patients are currently being followed to determine long term outcomes. . Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. Thank you, {{form.email}}, for signing up. Orthop J Sports Med. Second, the BEAR treated ACL position is more natural than the result of ACLR surgery. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. PDF December 16, 2020 - Food and Drug Administration J Orthop Res. Marketing authorization allows manufacturers to bring a medicinal product to the market. 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. (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. Before sharing sensitive information, make sure you're on a federal government site. Cision Distribution 888-776-0942 Bridge-enhanced anterior cruciate ligament repair (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with a specific extracellular matrix scaffold (the BEAR scaffold) that is placed in the gap between the torn ends of the ACL to facilitate ligament healing. The intact fibers have low signal intensity (black), reflecting highly organized tissue with little free water. Joint Fluid Proteome after Anterior Cruciate Ligament Rupture Reflects an Acute Posttraumatic Inflammatory and Chondrodegenerative State. Tian S, Wang B, Liu L, Wang Y, Ha C, Li Q, Yang X, Sun K. Am J Sports Med. and transmitted securely. Arthroscopy. 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). The experts explain how BEAR technology works and answer the most common questions about ACL injury and repair. 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. 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. 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. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not - PubMed (14) Nomura Y, Kuramochi R, Fukubayashi T. Evaluation of hamstring muscle strength and morphology after anterior cruciate ligament reconstruction. ACL injuries affect between 100,000 to 200,000 people in the U.S. each year. Outcomes-including the IKDC Subjective Score, the side-to-side difference in instrumented AP knee laxity, and muscle strength-were assessed at 2 years by an independent examiner blinded to the procedure. AOSSM checks author disclosures against the Open Payments Database (OPD). Annually in the United States, as many as 250,000 people suffer an ACL tear [2 . Study design: 8600 Rockville Pike Before 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. The patients also underwent arthrometry, a noninvasive measurement of laxityor loosenessof the knee joint. What if you could skip the surgery and instead have your Bone Marrow Concentrate (BMC), which contains healing stem cells, injected into your ACL? 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. Would you like email updates of new search results? 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 FDA assessed the safety and effectiveness of the BEAR Implant in a randomized controlled trial of 100 subjects with complete ACL rupture. Why? (5) Sanborn RM, Badger GJ, Proffen B, et al. An official website of the United States government. 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). Dr. Owens: During the course of my career, we have seen some small incremental changes to the surgical techniques in ACL reconstruction. Yang XG, Wang F, He X, Feng JT, Hu YC, Zhang H, Yang L, Hua K. Int Orthop. She said it had the potential to change the standard of care.. It doesnt require a second wound site to remove healthy tendon and does not involve donors. Background: Murray MM, Flutie BM, Kalish LA, Ecklund K, Fleming BC, Proffen BL, Micheli LJ. 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. 2020 May;48(6):1305-1315. doi: 10.1177/0363546520913532. Epub 2010 Jun 16. That may be tough to do using an MRI report, as the reading radiologist often doesnt differentiate between the two tear types. 2023 Mar;51(3):NP12-NP14. The results were excellent (more on those below). Epub 2020 Jun 25. Whether it replaces ACL reconstruction as the gold standard remains to be seen but I am optimistic it will, Fleming adds. Randomized controlled trial; Level of evidence, 1. Bridge enhanced ACL repair vs. ACL reconstruction for ACL tears: A systematic review and meta-analysis of comparative studies. BEAR-MOON? The preliminary work is very promising, but with any new research, we need more data to confirm the early findings, Lepley says. The BEAR implant is then injected with autologous whole blood. 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]). 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). Females Have Earlier Muscle Strength and Functional Recovery After The BEAR Implant is absorbed by the body as the ACL heals. (9) Kamien PM, Hydrick JM, Replogle WH, Go LT, Barrett GR. The ACL, a ligament located with the knee, is the tissue responsible for bridging the shinbone to the thigh bone. Benefits of BEAR ACL Repair in Pediatric Patients. 2017;45:97-105. 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. M.M.M. eCollection 2023 Apr. HHS Vulnerability Disclosure, Help Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. maintained a conflict-of-interest management plan that was approved by Boston Childrens Hospital and Harvard Medical School during the conduct of the trial, with oversight by both conflict-of-interest committees and the institutional review board of Boston Childrens Hospital, as well as the US Food and Drug Administration. The ACL implant isnt a traditional device like those used in most joint repairs. They had an average score of 88.9, while those who underwent traditional ACL repair had an average of 84.8. Ive summarized the comparison above. 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 . 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. -, Arneja S, Leith J. Cohort study; Level of evidence, 2. . 2023 Feb 20;24(1):8. doi: 10.1186/s10195-023-00688-5. Br J Sports Med. Researchers are hopeful this implant will become the new standard of care for ACL injuries. If you have questions or comments about this blog post, please email us at [emailprotected]. Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Commercial Availability of BEAR Implant - Miach Orthopaedics The FDA granted the marketing authorization to Miach Orthopaedics, Inc. 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. 2016 Oct;44(10):2579-2588. doi: 10.1177/0363546516655333. Clinical Research Progress of Internal Brace Ligament Augmentation Technique in Knee Ligament Injury Repair and Reconstruction: A Narrative Review. Compared to traditional ACL reconstruction, the implant is a less invasive procedure that restores the knees natural anatomy and function. Fleming says the FDA approval was exciting news that provides a treatment alternative to ACL reconstruction that does not require removing the injured ligament and replacing it with a graft of tendon.. First, BEAR allows the ACL to repair itself rather than ripping out the ACL remnants and placing a tendon as a substitute. Patients report more satisfaction in terms of pain, symptoms, and readiness. In 2020 Murray et al reported the outcome results of their Level I randomized-controlled trial examining a similar cohort of patients . Hence, you would need a Regenexx network physician to look at your actual MRI images. Murray also believes the implant will be a new gold standard for ACL repair in the future. However, as shown above, just like an ACL reconstruction, the BEAR implant surgery still has the physician drill tunnels. Registration: Conclusion: The Regenexx perc-ACLR procedure should be applied in patients that have a complete ACL tear, but the two ends are still connected. These promising results suggest that longer-term studies of this technique are justified. There were no graft or repair failures in the first 24 months after surgery. Bookshelf 2006;34(1):128135. Murray points out that patients who incurred an ACL months ago or who have little ACL tissue left would be more likely to benefit from an ACL reconstruction, rather than this implant. New technique for ACL repair taps body's own healing power Reduced knee laxity and failure rate following anterior cruciate ligament reconstruction compared with repair for acute tears: a meta-analysis. Epub 2023 Apr 13. 2021 Nov 9;9(11):23259671211052530. doi: 10.1177/23259671211052530. 2023;9:8. doi: 10.1051/sicotj/2023007. The BEAR-MOON trial addresses the question of whether this new and less invasive surgical procedure can provide non-inferior outcomes to the gold standard of treatment in terms of knee laxity, a common test to evaluate the integrity of the ACL, and patient-reported outcomes. J Transl Med. Read our. Ortop Traumatol Rehabil. Murray, M, et al. The BEAR Implant is the first medical advancement to enable your body to heal its own torn anterior cruciate ligament (ACL). 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. An erratum has been published: J Bone Joint Surg Am. has received educational funding from Kairos Surgical and hospitality payments from Smith & Nephew and Kairos Surgical. When I first heard about the BEAR ACL implant, I believed that the surgeon would place it in the correct spot and perhaps tack it down, meaning a far less invasive procedure than drilling graft tunnels. Bridge-enhanced Anterior Cruciate Ligament Repair (BEAR) Implant Patient reviews and testimonials on this site should not be interpreted as a statement on the effectiveness of our treatments for anyone else. 2015 Jul 31;8:437-47. doi: 10.2147/JPR.S86244. 2013 Aug;41(8):1808-12. doi: 10.1177/0363546513493896.

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