Medical Professionals

BEAR^® Implant

The Bridge-Enhanced^® ACL Repair (BEAR^®) implant is a proprietary bio-engineered sponge designed as a bridging scaffold to facilitate healing of the torn ACL.

The BEAR implant is 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. The combination of the BEAR implant and the patient’s blood provides a scaffold that allows the torn ends of the ACL to heal back together.

Illustration of the BEAR® implant process. Figure 1: Torn ACL. Figure 2: Place BEAR® implant between torn ACL ends. Add blood. Figure 3: Pull torn ACL ends into implant with stitches. Figure 4: Healing ACL tissue replaces BEAR® implant.

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.

Watch this video to find out more about how the BEAR implant works.

Watch this video to find out more about ACL tears, the BEAR implant and the first patient to receive it.

BEAR Clinical Trials

Several clinical trials are underway to study the BEAR implant and its safety and efficacy.

BEAR I: Enrollment is completed in this single-center, non-randomized, two-arm study that compared 10 patients treated with the BEAR implant to 10 patients treated with hamstring autograft ACL reconstruction.
BEAR II: Enrollment is completed in this single-center, non-randomized, two-arm study that compared 65 patients treated with the BEAR implant to 35 patients treated with autograft ACL reconstruction.
BEAR III: Enrollment of 250 patients is ongoing in this study taking place at Boston Children's Hospital and Rhode Island Hospital. Patients who may be eligible for the single-arm, cohort study:

will be ages 12 to 35
will be seen within 3 weeks of injury by a Boston Children's Hospital or Rhode Island Hospital participating surgeon
cannot have a history of prior ACL surgery on the affected knee
must not use tobacco, corticosteroids, or have a history of diabetes or inflammatory arthritis or any condition that could affect healing
BMI <35 (will be measured in clinic)
must not have an allergy to bovine collagen (cow protein)

To see if your patient is eligible to participate, email:

Boston Children’s Hospital at: bear.trial@childrens.harvard.edu
Rhode Island Hospital at: bear.trial@lifespan.org

BEAR MOON: Enrollment of 200 patients will begin later in 2019 in this randomized, controlled trial being conducted by Cleveland Clinic at five centers of excellence. The trial will compare patients treated with the BEAR implant to standard autograft patellar tendon reconstruction. The BEAR MOON trial is supported by a $6 million RO1 grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institutes of Health. For more information about the trial refer to https://clinicaltrials.gov/ct2/show/NCT03776162?term=BEAR+MOON&rank=1

Publications

Clinical Study Results

Orthopedic Journal of Sports Medicine: “The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study.” November 2016
https://www.ncbi.nlm.nih.gov/pubmed/?term=The+Bridge-Enhanced+Anterior+Cruciate+Ligament+Repair+(BEAR)+Procedure%3A+An+Early+Feasibility+Cohort+Study

Preclinical Study Results