Status:
RECRUITING
Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Womack Army Medical Center
Conditions:
Osteoarthritis, Knee
Anterior Cruciate Ligament Injuries
Eligibility:
All Genders
16-35 years
Phase:
NA
Brief Summary
The goal of this randomized clinical trial is to evaluate the effects of vibration on factors related to the risks of post-traumatic knee osteoarthritis and secondary anterior cruciate ligament (ACL) ...
Detailed Description
Background: Post-traumatic knee osteoarthritis (PTOA) is a leading cause of medical separation from military service. Anterior cruciate ligament (ACL) injury and surgical reconstruction (ACLR) incurs ...
Eligibility Criteria
Inclusion
- Age 16 to 35 years
- Unilateral, primary ACLR with bone-patellar tendon-bone autograft
Exclusion
- History of prior ACL injury or revision ACLR
- History of prior knee surgery
- Requirement of multiple ligament surgery at time of ACLR
- Concomitant injuries or surgical procedures at the time of ACLR that would delay early post-operative weight bearing based on surgeon recommendations (e.g. lower extremity fracture, intra-articular fracture, microfracture procedure)
- Removal of more than 1/3 of the medial or lateral meniscus at the time of ACLR
- Articular cartilage damage greater than 3A on the International Cartilage Repair Society Criteria at the time of ACLR
- History of musculoskeletal injury to either leg in the 3 months prior to participation other than primary ACL injury
- Prior diagnosis of radiographic OA in any joint of the lower extremity
- History of neurological disorder (e.g. stroke, multiple sclerosis, etc.)
- Contraindications for MRI (e.g. extreme claustrophobia, cardiac pacemaker, cochlear implant, metal foreign bodies, aneurism clip, etc.)
- Pregnant or planning to become pregnant
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04875052
Start Date
January 11 2021
End Date
August 1 2026
Last Update
May 31 2025
Active Locations (2)
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1
MOTION Science Institute
Chapel Hill, North Carolina, United States, 27599
2
Womack Army Medical Center
Chapel Hill, North Carolina, United States, 27599