WESTBOROUGH, Mass– A major clinical trial comparing a new treatment for anterior cruciate ligament (ACL) tears to the standard surgical approach has finished enrolling participants, researchers announced this week.
The BEAR MOON study, supported by the National Institutes of Health (NIH), is assessing the effectiveness of the BEAR® (Bridge-Enhanced ACL Restoration) Implant against the commonly used bone-patellar tendon-bone (BPTB) graft used in ACL reconstruction surgery. The trial involves 150 patients between the ages of 18 and 55 who were randomly assigned to one of the two procedures at the time of surgery.
Led by the Cleveland Clinic, the study is part of the Multicenter Orthopaedic Outcomes Network (MOON) and is being conducted at six medical centers across the United States. These include Brown University/Rhode Island Hospital, The Ohio State University, TRIA Orthopaedics/University of Minnesota, University of Colorado, and Vanderbilt University.
The BEAR Implant is designed to help the body heal its own torn ACL, offering a potential alternative to using a graft from the patient’s own tissue. Earlier studies have focused on comparing the implant to hamstring grafts. This new trial is the first large-scale effort to compare it with the BPTB technique, which is one of the most frequently used options in ACL reconstruction.
“This study will offer important insights into how the BEAR Implant performs relative to a widely used graft option,” said Dr. Kurt Spindler, principal investigator and associate chief of clinical research at the Cleveland Clinic.
Patients in the study will be followed for two years, with outcomes assessed at six months, one year, and two years post-surgery. Results from the trial are expected to be submitted for publication after the final follow-up period.
The research is funded by a $6 million grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, a branch of the NIH.
