MedTrace Logo

Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)

NCT02292004 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-17

No results posted yet for this study

Summary

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.)

Conditions

  • Anterior Cruciate Ligament Injury
  • Anterior Cruciate Ligament Tear

Interventions

DEVICE

ACL Repair with MIACH Scaffold

Surgical insertion of the MIACH scaffold to promote ACL healing/repair

PROCEDURE

Standard ACL Reconstruction

Standard surgical reconstruction of the ACL with autograft hamstring tendon

Sponsors & Collaborators

  • Miach Orthopaedics

    lead INDUSTRY

Principal Investigators

  • Lyle Micheli, MD · Boston Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2018-03-19
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02292004 on ClinicalTrials.gov