An Alternative to ACL Surgery?

The US Food and Drug Administration (FDA) has approved an implant that could provide an alternative to anterior cruciate ligament (ACL) reconstruction surgery.

The FDA approved this implant, called the Bridge-Enhanced ACL Repair (BEAR) Implant, to be an alternative to reconstruction to repair ACL tears. Recipients must be at least 14 years old and have a complete ACL rupture.

A ligament that keeps the knee stable, the ACL is often torn during sports or other high-impact physical activities.

“Torn ACLs are among the most common knee injuries in the U.S., but for years, treatment has been limited to ACL reconstruction, which can be quite invasive and typically requires using tendon or a combination of tendon and bone from other parts of the body, or obtained from a tissue bank, to complete the reconstruction,” said Capt. Raquel Peat, PhD, director of the FDA's Office of Orthopedic Devices, in a press release. “Today’s marketing authorization provides new options for the hundreds of thousands of people affected by ACL rupture in the U.S. each year.”

This new implant does not use harvested tendons to repair a torn ACL. Instead, it is secured to the torn ends of the ACL to create a "bridge" to reconnect the torn ligament. According to the FDA, during the eight weeks after the implant is placed, your body is meant to absorb it and replace it with your own tissue.

The FDA assessed this ACL repair implant's safety and effectiveness in a trial of 100 patients with ACL tears. Some received the implant, and others received traditional ACL repair surgery. Two years later, both groups of patients reported similar improvements in knee function, pain and stiffness.

Some complications reported with the BEAR Implant included the need for additional surgeries due to failures with grafting or repair.

The FDA approved this implant for Miach Orthopaedics, Inc.

If you are experiencing knee pain or an ACL tear, talk to your health care provider about your treatment options.