ACL Repair with MIACH Scaffold for Anterior Cruciate Ligament Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anterior Cruciate Ligament Injury+2 More
ACL Repair with MIACH Scaffold - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Anterior Cruciate Ligament Injury
  • Anterior Cruciate Ligament Tear

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: At 3-months post-op

At 3-months post-op
Implant failure
At 6- and 12-months post-op
Anteroposterior (AP) knee laxity
At 6-weeks post-op
Muscle Atrophy
Surgery to 3-months post-op
Excessive Pain
Inflammatory reaction
Safety and tolerability of the BEAR® Implant

Trial Safety

Trial Design

2 Treatment Groups

Standard ACL reconstruction
1 of 2
ACL repair with MIACH scaffold
1 of 2

Active Control

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: ACL Repair with MIACH Scaffold · No Placebo Group · Phase 1

ACL repair with MIACH scaffold
Device
Experimental Group · 1 Intervention: ACL Repair with MIACH Scaffold · Intervention Types: Device
Standard ACL reconstruction
Procedure
ActiveComparator Group · 1 Intervention: Standard ACL Reconstruction · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 3-months post-op

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
Lyle Micheli, MDPrincipal InvestigatorBoston Children's Hospital
Martha Murray, MDStudy DirectorBoston Children's Hospital

Eligibility Criteria

Age 18 - 65 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
is not a reliable predictor of ACL tear The ACL tissue present on a pre-operative MRI is not a reliable predictor of an ACL tear.
The patient's ACL has been completely torn, as confirmed by an MRI scan.
A patient must be screened for eligibility for a clinical trial within 90 days of the injury.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.