MIACH Scaffold for ACL Tear

(BEAR Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Miach Orthopaedics

Must not be taking: Corticosteroids

Disqualifiers: Tobacco use, Chemotherapy, Diabetes, others

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

Compensation: Varies

Number of Visits: 7

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)

Research Team

Lyle Micheli, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

This trial is for individuals with a complete ACL tear confirmed by MRI, and the injury must have occurred within the last 90 days. Participants should still have some ACL tissue visible on pre-operative MRI.

Inclusion Criteria

Complete ACL tear, confirmed by MRI

Time from injury to screening must be less than or equal to 90 days

ACL tissue present on pre-operative MRI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo ACL repair surgery using the MIACH scaffold or standard ACL reconstruction

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for safety and early efficacy, including inflammatory reactions, muscle atrophy, and excessive pain

3 months

Regular follow-up visits

Follow-up

Participants are monitored for long-term outcomes such as AP knee laxity

12 months

Follow-up visits at 6 and 12 months

Treatment Details

Interventions

• MIACH Scaffold

Trial Overview The study compares a new device called MIACH Scaffold used in repairing torn ACLs against standard ACL reconstruction surgery. It will involve 10 people getting the new treatment and another 10 receiving traditional surgery.

Participant Groups

Group I: ACL repair with MIACH scaffold Experimental Treatment 1 Intervention

Patients will undergo ACL repair surgery using the newly developed MIACH scaffold

Group II: Standard ACL reconstruction Active Control 1 Intervention

Patients will undergo a standard ACL reconstruction surgery

Who Is Running the Clinical Trial?

Miach Orthopaedics

Lead Sponsor

Trials

5

Recruited

1,300+