20 Participants Needed

MIACH Scaffold for ACL Tear

(BEAR Trial)

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Miach Orthopaedics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.)

Who Is on the Research Team?

LM

Lyle Micheli, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: ACL repair with MIACH scaffoldExperimental Treatment1 Intervention
Group II: Standard ACL reconstructionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Miach Orthopaedics

Lead Sponsor

Trials
5
Recruited
1,300+
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