Bridge-Enhanced ACL Repair-Safety Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anterior Cruciate Ligament Injury
- Sponsor
- Miach Orthopaedics
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of the BEAR® Implant
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.)
Detailed Description
This is a first-in-human trial for evaluation of the safety (Primary Objective) and short-term efficacy (Secondary Objective) of the MIACH™ ACL scaffold and will be carried out in form of an observational study of 20 patients: 10 experimental and 10 control.
Investigators
Eligibility Criteria
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
- •Exclusion Criteria (before surgery):
- •Prior surgery on affected knee
- •History of prior infection in affected knee
- •Regular use of tobacco or nicotine in any form
- •Use of corticosteroid within last 6 months
- •Ever underwent chemotherapy treatment
- •History of sickle cell disease
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety and tolerability of the BEAR® Implant
Time Frame: Surgery to 3-months post-op
To assess the safety (implant rejection, infection, joint effusion, muscle atrophy, knee laxity) and tolerability of the BEAR® implant
Secondary Outcomes
- Muscle Atrophy(At 6-weeks post-op)
- Implant failure(At 3-months post-op)
- Inflammatory reaction(Surgery to 3-months post-op)
- Excessive Pain(Surgery to 3-months post-op)
- Anteroposterior (AP) knee laxity(At 6- and 12-months post-op)