BEAR Scaffold vs ACL Reconstruction for ACL Tear

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Miach Orthopaedics

Must not be taking: Corticosteroids

Disqualifiers: Diabetes, Inflammatory arthritis, Sickle cell, others

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

Compensation: Varies

Number of Visits: 6

Duration: Surgery and immediate recovery

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used corticosteroids in the last 3 months.

What data supports the effectiveness of the treatment BEAR Scaffold for ACL Tear?

Research shows that the BEAR Scaffold treatment for ACL tears has similar patient-reported outcomes to traditional ACL reconstruction after two years, and it may help patients recover faster in terms of knee pain, strength, and return to sports. ^{1 2 3 4 5}

Is the BEAR Scaffold safe for humans?

The BEAR Scaffold, used in ACL repair, has been studied for safety, and early research shows it does not have a significant rate of adverse reactions in humans. ^{1 2 3 4 5}

How is the BEAR Scaffold treatment different from other ACL tear treatments?

The BEAR Scaffold treatment is unique because it uses a special scaffold to bridge the gap between the torn ends of the ACL, promoting natural healing, unlike traditional ACL reconstruction which typically involves replacing the torn ligament with a tendon graft. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this trial is to compare the efficacy of the Bridge-Enhanced Anterior Cruciate Ligament Repair (BEAR™) technique with the current method of treatment for anterior cruciate ligament (ACL) injuries, ACL reconstruction.

Research Team

Yi-Meng Yen, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

This trial is for males and females aged 14-35 with a complete ACL tear, who can have surgery within 45 days of injury. Participants must not have had previous knee surgeries or infections, use tobacco, or have conditions affecting healing like diabetes.

Inclusion Criteria

My gender does not affect my eligibility.

I am between 14 and 35 years old.

My MRI shows at least half of my ACL is still attached to the bone in my lower leg.

Exclusion Criteria

I have had surgery on my knee before.

I have undergone chemotherapy.

I have had an infection in my knee before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either the Bridge-Enhanced ACL Repair (BEAR) technique or ACL reconstruction

Surgery and immediate recovery

Follow-up

Participants are monitored for knee function and stability, with assessments at 6 months and 2 years post-surgery

2 years

Multiple visits for assessments at 6 months and 2 years

Long-term follow-up

Participants are monitored for long-term outcomes, including knee stability and function

10 years

Treatment Details

Interventions

• BEAR Scaffold
• Tendon Graft

Trial Overview The study compares the BEAR technique—a new method to repair ACL tears using a special scaffold—with traditional tendon graft reconstruction. The goal is to see which treatment is more effective for repairing ACL injuries.

Participant Groups

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

The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into.

Group II: Tendon Graft Active Control 1 Intervention

ACL reconstruction is when a tendon graft (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee) is taken and used to replace the torn ACL.

Who Is Running the Clinical Trial?

Miach Orthopaedics

Lead Sponsor

Trials

5

Recruited

1,300+

References

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

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

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

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

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

5. 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]