The FOI Department of Sports Medicine has been selected as one of only ten sites in the U.S. to participate in the Bridge Enhanced ACL Restoration (BEAR) III clinical trial. The BEAR implant is a resorbable collagen scaffold that when hydrated with the patient’s own blood, allows healing of the torn anterior cruciate ligament (ACL).
The incidence of ACL tears in the U.S. is estimated at 1 per 1,000 people. An anterior cruciate ligament injury has immediate and long-term consequences on a patient’s quality of life and is a known risk factor for the development of degenerative arthritis.
Historically, prior attempts at ACL repair had unacceptably high failure rates. The current surgical gold standard treatment for ACL tears involves removing the torn ligament and replacing it with a tendon graft. This is known as ACL reconstruction. Unfortunately, patients continue to exhibit progressive cartilage and joint damage even with successful surgery.
To improve long-term outcomes after an ACL injury, research has focused on better treatment options. This has resulted in the development of a novel repair technique using the BEAR implant. It eliminates the need to harvest a tendon from the patient, which is necessary for a traditional ACL reconstruction. The BEAR implant is FDA approved for the treatment of complete ACL tears. It is the first medical technology to clinically demonstrate that it enables the healing of the patient’s own torn ligament. Early studies have shown results equivalent to ACL reconstruction. The hope is that restoring normal anatomy and knee function using a BEAR implant will decrease the risk of arthritis over time.
ARE YOU A POTENTIAL CANDIDATE FOR THE TRIAL?
Potential participation in the trial would consider the following factors:
- Are 12-80 years of age
- Had an ACL tear within 50 days of the expected surgery date
- Have a BMI of less than 35 kg/m2
PARTICIPATING SURGEONS:
- Neil S. Kumar, MD, MBA
- Seth I. Gasser, MD
CONNECT WITH OUR RESEARCH TEAM TO SEE IF YOU QUALIFY TO PARTICIPATE OR ASK YOUR DOCTOR AT YOUR NEXT APPOINTMENT.
If you are interested in participating in this study, you can email the study team at: ClinicalResearch@FOREonline.org and put “BEAR Implant” in the subject line.
You can also call or email the research coordinator directly:
Debbi Warren
dwarren@foreonline.org
813-978-9700, x 6766
For more information about the clinical trial, including inclusion/exclusion criteria, please visit https://miachortho.com/patients-and-families/bear-implant/
