RecruitingNot Applicable

Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

United States114 participantsStarted 2021-01-11

Plain-language 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.

Who can participate

Age range

16 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 16 to 35 years * Unilateral, primary ACLR with bone-patellar tendon-bone autograft Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quadriceps Isometric Peak Torque Limb Symmetry Index over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Change in peak internal knee extension moment during walking over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Change in vertical ground reaction force instantaneous loading rate over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Change in KOOS Knee-related Quality of Life Subscale over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Probability of attaining 90% single-leg hop symmetry at 12 months post-ACLR.

Timeframe: Up to 12 months post ACL reconstruction surgery

Trial details

NCT IDNCT04875052

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08

Contact for this trial

Troy Blackburn, PhD

919-843-2021 troyb@email.unc.edu

View on ClinicalTrials.gov More Osteoarthritis, Knee trials

Plain-language summary

Who can participate

Age range

16 Years – 35 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Quadriceps Isometric Peak Torque Limb Symmetry Index over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Change in peak internal knee extension moment during walking over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Change in vertical ground reaction force instantaneous loading rate over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Change in KOOS Knee-related Quality of Life Subscale over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery

Timeframe: Up to 12 months post ACL reconstruction surgery

Probability of attaining 90% single-leg hop symmetry at 12 months post-ACLR.

Timeframe: Up to 12 months post ACL reconstruction surgery