BEAR Implant Compares with Traditional ACL Reconstruction

Results to be presented at the forthcoming Arthroscopy Association of North America (AANA)/American Orthopaedic Society for Sports Medicine (AOSSM) 2019 Specialty Day will suggest that the Bridge-Enhanced® ACL Repair (BEAR®) procedure delivers a similar clinical, functional and patient-reported outcomes compared to patients undergoing autograft Anterior Cruciate Ligament (ACL) reconstruction 24 months after surgery.

Background

Miach Orthopaedics, Inc., dedicates itself to developing bio-engineered surgical implants for connective tissue repair. Its Bridge-Enhanced® ACL Repair (BEAR®) implant is a proprietary bio-engineered bridging scaffold to facilitate healing of the torn ACL. It is designed to be surgically placed between the torn ACL ends at the time of repair, and to physically 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. It is hoped this new technology will restore more normal anatomy and function of the knee, and thus enable a higher percentage of patients to get back to activities they enjoy. The BEAR implant is an investigational device and is only available in FDA approved clinical trials.

The BEAR I non-randomized, two-arm study, conducted at Boston Children’s Hospital, compared 10 patients treated with the BEAR implant to 10 patients treated with hamstring autograft ACL reconstruction. It was conducted under a U.S. FDA Investigational Device Exemption. Consistent with earlier findings the study delivered 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.

Investigator comments

“It has been four years since we initiated human studies of ACL injury repair using the BEAR scaffold,” said Lyle J. 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, comparing 10 BEAR repaired knees with 10 treated with ACL reconstruction with autograft. 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.”

Company comments

“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 Martha Murray, M.D., professor of orthopaedic surgery at Harvard Medical School, an orthopaedic surgeon in the Sports Medicine Division at Boston Children’s Hospital and founder of Miach Orthopaedics. “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.”

Source: Miach Orthopaedics

 

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