Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury
The Effects of Vibratory Stimuli on Joint Health and Post-traumatic Osteoarthritis Risk Following Anterior Cruciate Ligament Injury
University of North Carolina, Chapel Hill
114 participants
Jan 11, 2021
INTERVENTIONAL
Conditions
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) injury in individuals who have undergone anterior cruciate ligament reconstruction surgery (ACLR). The main objectives are to compare the effects of Standard rehabilitation vs. rehabilitation that includes whole body vibration (WBV) or local muscle vibration (LMV) on: * Quadriceps muscle function * Gait biomechanics linked to post-traumatic knee osteoarthritis development * Patient self-report outcomes * MRI indicators of knee joint health and muscle quality * Landing biomechanics linked to secondary ACL injury risk * Evidence-based return-to-physical-activity criteria Participants will be assigned to 1 of 3 groups (standard rehabilitation, standard rehabilitation + WBV, or standard rehabilitation + LMV) and will complete assessments of quadriceps function, gait biomechanics, landing biomechanics, functional ability, patient-report outcomes, and MRI 1, 6, and 12 months after ACLR. Researchers will compare the groups to see if vibration embedded in ACLR rehabilitation improves joint health outcomes.
Eligibility
Inclusion Criteria2
- Age 16 to 35 years
- Unilateral, primary ACLR with bone-patellar tendon-bone autograft
Exclusion Criteria11
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Whole body vibration will be delivered using a commercially available device at a frequency of 30Hz and acceleration of 2g for 1 minute a total of 6 times with 2 minutes of rest between exposures.
Local muscle vibration will be delivered using a prototype device at a frequency of 30Hz and acceleration of 2g for 1 minute a total of 6 times with 2 minutes of rest between exposures.
Patients will complete a standard of care rehabilitation emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04875052