Expanding BEAR® technology across the United States
The BEAR-MOON trial aims to compare the BEAR® technique against standard anterior cruciate ligament (ACL) reconstruction with a graft.
The study is enrolling 200 patients aged 18 to 55 who have recently sustained an ACL tear into one of two arms: traditional ACL reconstruction with a patellar tendon graft, or ACL restoration using the BEAR® implant. Patients have a 50% chance of being randomized into either arm, and neither the patient nor the research investigator can choose which arm will be selected. After the surgery, patients will undergo a nine-month physical therapy regimen and will participate in several research activities over the course of two years including functional knee assessments, x-ray imaging, and patient-reported health assessments.
This multi-site research study is being conducted at multiple hospitals in the United States that are experienced in orthopaedic research. The study Principal Investigator is Dr. Kurt Spindler, Director of Clinical Research and Outcomes of Cleveland Clinic Florida and Co-Director of the Cleveland Clinic Musculoskeletal Research Center. This study is approved by the FDA and is being funded by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
Most of the physicians involved in the trial have completed an accredited fellowship in sports medicine due to the specific needs of the field. These fellowships usually last one or two years and give the physicians a chance to improve their skills and gain more experience in the specialty of sports medicine. Some of the organizations include the American College of Sports Medicine, the American Orthopaedic Society for Sports Medicine, the American Orthopaedic Association, and the American Medical Society for Sports Medicine. The physicians continue to expand their expertise in this field through continuing education and participation in sports medicine.
The BEAR-MOON is currently open for enrollment. Individuals who have recently suffered an ACL injury and are between the ages of 18 and 55 may be candidates to participate in the trial. Continue reading about BEAR-MOON enrollment...