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The anterior cruciate ligament (ACL) is a ligament in your knee that keeps it moving normally. When the ACL is torn, some patients need surgery to make the knee stable enough to return to their normal activities. ACL injuries have immediate and long-term effects on the quality of life and are known risk factors for post-traumatic osteoarthritis (inflammation of one or more joints). ACL injuries are also incredibly common, with more than 100,000 – 200,000 ruptures reported each year.
MedStar Health is a part of a collaborative research study sponsored by Miach Orthopaedics to assess safety and effectiveness of the BEAR ® implant, a new surgical treatment for ACL tears, measured by patient reported outcomes, and objective assessments. The study “A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR®)” is led by Dr. Richard Levine, medical director for sports medicine clinical services at MedStar Union Memorial Hospital.
This study is testing a new surgery called the BEAR (Bridge-Enhanced ACL Restoration) procedure, which uses a new device called the BEAR® Implant, to determine if the treatment improves outcomes. In a standard ACL surgery, the surgeon reconstructs the torn ACL using a graft (piece of tendon from another part of your body) to replace the torn ACL.
Instead of reconstructing the ACL using a graft, the surgeon will use the BEAR Implant, which is made from purified bovine (cow) collagen, to bridge the ACL stump to the bone using stitches to stimulate restoration. The implant is filled with some of your own blood which helps the ACL grow back together. An advantage of using the BEAR Implant is that the surgeon does not need to take any normal tissues from another part of your body.
Studies using this procedure have shown that patients’ knees that are as stable and strong at two years after surgery as those patients who had a graft placed by the standard method. However, it is too soon to know if patients who had the BEAR Implant will have less arthritis. 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.
The study will continue to monitor knee stability and outcomes for 10 years following the procedure, with 9 post-operative visits taking place throughout the duration of the study. Outcomes will be measured using the International Knee Documentation Committee (IKDC) subjective and objective score. Additional outcomes will be measured using a physical exam, additional patient reported outcome measures, imaging (MRI and x-ray), and adverse events (including range of motion, incidence of deep joint infection or inflammatory/immune reaction, repair failure and rates of additional surgery) as well as muscle strength.
MedStar Health currently has the second highest recruitment rate in the country for this study, and the team of investigators are hopeful in seeing positive results for patients with ACL tears.
Want to participate in this study?
Have you experienced an ACL injury and need surgery? Email JoinResearch@medstar.net to learn more about this study or participate.