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 10 patients who underwent traditional ACL repair. It 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.
Outcomes reported included International Knee Documentation Committee (IKDC) subjective and objective results, knee anteroposterior (AP) laxity findings via an arthrometer, and functional outcomes. IKDC subjective scores improved from baseline (P < .0001) at 12 and 24 months, to 84.6 ± 17.2 in the ACLR group and to 91.7 ± 11.7 in the BEAR group. An IKDC objective grade of A (normal) was found in 44% of patients in the BEAR group and in 29% of patients in the ACLR group at 24 months. The two groups demonstrated similar mean side-to-side differences in arthrometer testing and similar results in functional hop testing. Hamstring strength indices were significantly higher in the BEAR group compared with the ACLR group.
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. The study’s results were 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.”