← Back to Search

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

BEAR Trial 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.Check my eligibility
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.See study design
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.

BEAR Trial 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

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

BEAR 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
2 Trials studying Anterior Cruciate Ligament Tear
300 Patients Enrolled for Anterior Cruciate Ligament Tear
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 Tear Research Study Groups: ACL repair with MIACH scaffold, Standard ACL reconstruction
Anterior Cruciate Ligament Tear 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial encompass seniors as participants?

"The age range for those eligible to join this trial is from 18 years old up until 35."

Answered by AI

Has the MIACH Scaffold for ACL Repair been approved by the FDA?

"The potential safety of ACL Repair with MIACH Scaffold was rated a 1, as this is an early-stage trial that has generated limited data on both effectiveness and safety."

Answered by AI

Is it possible for me to enroll in this investigation?

"This medical trial aims to enrol 20 individuals, aged 18-35 years old and suffering from a recent ACL injury (aside from 90 days of onset)."

Answered by AI

Does the research team continue to accept participants for this investigation?

"The evidence found on clinicaltrials.gov reveals that this trial is not currently seeking patient volunteers; the first posting of this study was in January 2015, with its last update being March 2021. However, there are 100 other medical trials actively enrolling patients at present."

Answered by AI
Recent research and studies
~2 spots leftby Mar 2025