Kurt P. Spindler, MD, of Cleveland Clinic and founder of the Multicenter Orthopaedic Outcomes Network (MOON) Group, has received a 5-year, $6 million grant to study techniques used for anterior cruciate ligament (ACL) reconstruction. The grant, awarded by the National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases, supports a multi-center, randomized clinical trial aimed at determining if outcomes of a new surgical technique, Bridge-Enhanced® ACL Repair (BEAR®), are equal to or better than outcomes of the standard autograft patellar tendon reconstruction, at 6, 12, and 24 months post surgery. The BEAR procedure begins with drilling small tunnels to place a suture into the ACL fibers and stabilize the knee. The tissue-engineered scaffold, invented by Martha Murray, MD, at Boston Children’s Hospital, is implanted through a small incision in the knee. Surgeons then pull the stitched ACL tibial stump into the scaffold as the knee is extended. The patient’s own blood is applied to the scaffold to provide growth factors and stimulate healing.
“The current standard for ACL surgery is a complex reconstruction procedure that has a high rate of success in terms of return to sports and activities of daily living. But the failure rate is high in adolescents,” said Spindler, who is also the lead investigator. “There is some graft site morbidity and the propensity to develop early posttraumatic osteoarthritis (PTOA) is not prevented.”
This research will build upon prior studies led by Murray that showed the BEAR technique to have similar results to ACL reconstruction in preclinical and early clinical studies. Researchers expect earlier improved range of motion and knee kinematics in the short term and no graft harvest morbidity for the patients treated with Bridge-Enhanced ACL Repair. The BEAR implant is an investigational device and is only available for use in U.S. Food and Drug Administration–approved clinical trials.
The cohort will include 200 participants who are between 18 and 40 years old and have complete ACL tears. Surgery will take place within 50 days of the injury. Patients are expected to return to normal activities in a few months and to sports in about 9 months, Spindler noted.