BEAR Procedure for ACL Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new procedure called BEAR for treating ACL injuries. It uses an implant and the patient's blood to help heal the torn ligament. The study aims to see if age affects how well patients recover from this procedure. The BEAR technique combines repairing the ACL with a special material placed in the gap between the torn ends to help healing.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes people using corticosteroids or undergoing chemotherapy.
Is the BEAR procedure for ACL injuries safe for humans?
How is the BEAR treatment different from other ACL injury treatments?
The BEAR treatment is unique because it uses a special scaffold to help the torn ACL heal naturally, unlike traditional ACL reconstruction which replaces the torn ligament with a graft. This approach aims to restore the original ligament and may lead to quicker recovery of knee function and less pain.12356
What data supports the effectiveness of the BEAR treatment for ACL injury?
Are You a Good Fit for This Trial?
The BEAR III Trial is for individuals who have recently (within 50 days) injured their ACL and still have at least 5% of the ligament attached to the tibia. It's not suitable for those with allergies to bovine products or gelatin, a BMI over 35, history of knee issues like infections or moderate osteoarthritis, prior knee surgery, tobacco use, or severe allergic reactions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo the Bridge-Enhanced ACL Restoration (BEAR) procedure, where an implant is placed between the torn ends of the ACL to stimulate healing
Follow-up
Participants are monitored for safety and effectiveness, including knee stability and function, up to two years after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Bridge-Enhanced ACL Restoration (BEAR)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Miach Orthopaedics
Lead Sponsor