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Scaffold

MIACH Scaffold for ACL Tear (BEAR Trial)

N/A
Waitlist Available
Led By Lyle Micheli, MD
Research Sponsored by Miach Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3-months post-op
Awards & highlights
No Placebo-Only Group

Summary

This trial will test a new device for repairing a torn ACL. 10 patients will use the new device, and 10 will have standard ACL surgery.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed, they may include typical surgical risks such as pain at the site, infection, swelling, bleeding, or adverse reactions to anesthesia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3-months post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3-months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of the BEAR® Implant
Secondary study objectives
Anteroposterior (AP) knee laxity
Excessive Pain
Implant failure
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ACL repair with MIACH scaffoldExperimental Treatment1 Intervention
Patients will undergo ACL repair surgery using the newly developed MIACH scaffold
Group II: Standard ACL reconstructionActive Control1 Intervention
Patients will undergo a standard ACL reconstruction surgery

Find a Location

Who is running the clinical trial?

Miach OrthopaedicsLead Sponsor
4 Previous Clinical Trials
1,300 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Injury
250 Patients Enrolled for Anterior Cruciate Ligament Injury
Martha Murray, MDStudy DirectorBoston Children's Hospital
Lyle Micheli, MDPrincipal InvestigatorBoston Children's Hospital

Media Library

MIACH Scaffold (Scaffold) Clinical Trial Eligibility Overview. Trial Name: NCT02292004 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: ACL repair with MIACH scaffold, Standard ACL reconstruction
Anterior Cruciate Ligament Injury Clinical Trial 2023: MIACH Scaffold Highlights & Side Effects. Trial Name: NCT02292004 — N/A
MIACH Scaffold (Scaffold) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02292004 — N/A
~2 spots leftby Nov 2025
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