Pediatric Orthopedic Surgery Team Reaches Milestone with Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR®) Implant and Advances Surgical Approach

On November 27, AdventHealth for Children pediatric orthopedic surgeon Sean Keyes, DO, Katelyn Smith, PA-C, and their team performed their 100^th bridge-enhanced anterior cruciate ligament (ACL) repair (BEAR®) procedure, the first pediatric team in the country to reach this milestone.

A bio-engineered implant that facilitates healing of a patient’s native torn ACL, BEAR is an alternative approach to traditional ACL reconstruction or replacement. It became commercially available in January 2022, and Dr. Keyes became the first in Central Florida and the second in the state of Florida to perform a pediatric BEAR implant procedure.

“As both a pediatric sports medicine specialist and father of four athletic kids, I know how devastating a torn ACL can be,” shares Dr. Keyes. “In the younger population especially, ACL repairs traditionally don’t do well, carrying a high risk of re-injury and leading to long-term arthritis. With the BEAR implant, our goal is to make ACL healing more reliable. It offers our patients a more natural solution that works with their bodies as they continue growing.”

Pioneering New BEAR Implant Surgical Approaches to Improve Patient Outcomes

Since 2022, Dr. Keyes and his team have been refining their surgical approach for the BEAR procedure, developing new techniques with the goal of enhancing outcomes for pediatric patients. This includes the following advancements:

• A growth-plate sparing procedure for younger patients that involves placing a button on the tibia and an anchor on the femur
• A two-anchor approach for cases where the growth plates are already closed

“We also now perform our BEAR implant procedures arthroscopically using an even smaller incision,” says Dr. Keyes. “This evolved from our two-anchor technique.”

Most recently, Dr. Keyes and Smith changed the way they deliver the BEAR implant.

“The BEAR implant is a bovine collagen sponge about the size of a packing peanut. It starts off hardened and when injected with autologous whole blood, softens and forms a stable blood clot,” explains Dr. Keyes. “In the early adoption period, we made an incision to open the knee and place the implant into the knee after hydrating it. Now we cut the implant and place it in a syringe along with the patient’s whole blood, mixing the two outside the body before injecting the combined gelatin-like substance into the knee. This allows us to use a much smaller incision and achieve more accurate delivery. The innovation has helped make the procedure minimally invasive and more efficient.”

Educating the Pediatric Orthopedic Surgery Community on BEAR

For more than two years, Dr. Keyes has also been actively involved in training and educating other pediatric orthopedic surgeons throughout the country on how to perform BEAR procedures. This includes conducting individual physician training sessions and speaking at national medical meetings as well as producing a continuing medical education (CME) course called “Revolutionizing the Bridge to ACL Restoration” available through HMP Education and a Case Review for the BEAR Implant medical education webinar through Micah Orthopaedics.

Additional Research and the Future of BEAR

Research on the BEAR implant has continued since its De Novo approval by the U.S. Food and Drug Administration (FDA) in December 2020. The device is currently indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by magnetic resonance imaging (MRI). Patients must have an ACL stump of at least 1 cm attached to the tibia to facilitate the restoration, and it is recommended that the BEAR device be implanted within 50 days of injury.

The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration study has been exploring the use of the BEAR implant for partial tear repair as well as the potential to expand the criteria down to age 12. It recently closed, but the findings have not yet been published. A second study, A Comparison of ACL Repair with BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction (BEAR-MOON), is further evaluating the effectiveness of the BEAR implant, including for higher-level athletes, and should close soon.

“We’re working with the FDA to expand the age indications for BEAR to eliminate the lower age limit and include our younger patients,” says Dr. Keyes. “We also hope to expand its usage to encompass partial ACL tears. Here at AdventHealth for Children, we’re excited about what we’re seeing with our BEAR patients. We continue to collect data and evaluate our outcomes, which we hope to publish soon.”