BEAR Procedure for ACL Injury

Recruiting at 13 trial locations

Overseen By Beth Trainor, BSN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Miach Orthopaedics

Must not be taking: Corticosteroids, Chemotherapy

Disqualifiers: Prior knee surgery, Tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

250 Participants Needed

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?

The BEAR procedure, which uses a special scaffold to help heal ACL tears, has been studied for safety. An early study specifically looked at whether the materials used in the procedure caused any harmful reactions, and it was designed to check for any significant adverse effects. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

What data supports the effectiveness of the BEAR treatment for ACL injury?

Research shows that the BEAR treatment, which helps heal ACL tears using a special scaffold, is as effective as traditional ACL reconstruction surgery at two years. It also suggests that patients may experience quicker relief from symptoms and regain function sooner with BEAR. ^{1 2 3 5 6}

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

At least 5% of my ACL is attached to my shinbone.

ACL tear within 50 days of injury

Exclusion Criteria

I am currently using or have used chemotherapy.

Use of tobacco

I have had a knee infection in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness, including knee stability and function, up to two years after surgery

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Bridge-Enhanced ACL Restoration (BEAR)

Trial Overview This trial tests the BEAR procedure where an implant soaked in the patient's blood aims to heal torn ACLs. The study focuses on whether age affects recovery by comparing outcomes using scores that measure knee function two years post-surgery.

How Is the Trial Designed?

Group I: Bridge-Enhanced ACL Restoration (BEAR) Experimental Treatment 1 Intervention

The BEAR technique involves surgically placing an absorbable implant (the BEAR Implant) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into

Who Is Running the Clinical Trial?

Miach Orthopaedics

Lead Sponsor

Trials

5

Recruited

1,300+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Design Features and Rationale of the BEAR-MOON (Bridge-Enhanced ACL Restoration Multicenter Orthopaedic Outcomes Network) Randomized Clinical Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Preoperative Risk Factors for Subsequent Ipsilateral ACL Revision Surgery After an ACL Restoration Procedure. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Earlier Resolution of Symptoms and Return of Function After Bridge-Enhanced Anterior Cruciate Ligament Repair As Compared With Anterior Cruciate Ligament Reconstruction. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Bridge-Enhanced Anterior Cruciate Ligament Repair: Two-Year Results of a First-in-Human Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Bridge-Enhanced Anterior Cruciate Ligament Repair Is Not Inferior to Autograft Anterior Cruciate Ligament Reconstruction at 2 Years: Results of a Prospective Randomized Clinical Trial. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

The Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR) Procedure: An Early Feasibility Cohort Study. [2022]