Miach Orthopaedics said that a study of its bio-engineered implant for autograft anterior cruciate ligament (ACL) repair revealed results similar to those achieved by traditional ACL repair surgeries two years post-procedure.
The non-randomized, two-arm study conducted at Boston Children’s Hospital enrolled 10 patients treated with Miach Orthopaedics’ bridging scaffold-enhanced ACL repair (BEAR) implant with hamstring autograft ACL reconstruction and was conducted under an FDA Investigational Device Exemption. The BEAR implant was designed to be surgically placed between the torn ACL ends at the time of repair, and to hold a small amount of the patient’s blood in the wound site. This provides a scaffold that allows the torn ends of the ACL to heal back together.
The BEAR I study assessed the safety and early efficacy of the BEAR implant to repair a torn ACL. In addition to similar clinical, functional and patient-reported outcomes, the procedure using the BEAR implant did not result in any patients having an infection or a severe inflammatory reaction, arthrofibrosis or a reaction that required scaffold removal. In addition, manual and instrumented measures suggest the stability of the knee after both procedures may be comparable. The study’s results will be presented at the American Academy of Orthopedic Surgeons (AAOS) conference on Specialty Day, March 16.
“In this small, first-in-human study, bridge-enhanced ACL repair with the BEAR implant had similar outcomes to ACL reconstruction with autograft hamstring,” said Boston Children’s orthopedic surgeon and Harvard University professor Martha Murray, M.D., in a prepared statement. “These results are promising and suggest the BEAR implant is worthy of further study. We’ve completed enrollment of 100 subjects in the BEAR II randomized controlled trial, and we look forward to those results.”
Murray is also the founder of Miach Orthopaedics, based in Westborough, Mass. The National Football League Players Assn. contributed to a nearly $23 million Series A round for the company in 2018.
“It has been four years since we initiated human studies of ACL injury repair using the BEAR scaffold,” said Lyle Micheli, M.D., director of Boston Children’s Hospital Division of Sports Medicine. “During this time, we have completed two clinical studies to evaluate this technique. The first was this BEAR I safety study…. The second was a randomized, blinded study of 100 patients, again comparing BEAR ACL repairs with autograft reconstruction. The early results of these studies have been encouraging. We are planning a third study to look further at the effects of age on the outcomes of this technique.”