NCT04875052 · University of North Carolina, Chapel Hill
Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury
What this study is about
The goal of this randomly assigned 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.
View original scientific description
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.
Interventions
DEVICE
Experimental: Whole Body Vibration
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.
DEVICE
Experimental: Local Muscle Vibration
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.
OTHER
Standard ACL Rehabilitation
Patients will complete a standard of care rehabilitation emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control.
Primary outcome measures
Quadriceps Isometric Peak Torque Limb Symmetry Index over the first 12 months following ACL reconstruction surgery
Time frame: Up to 12 months post ACL reconstruction surgery
Quadriceps function will be assessed via maximal voluntary isometric knee extension efforts while patients are seated on a dynamometer with the knee in 90° of flexion. Peak torque will be normalized to body mass. The limb symmetry index will be calculated as the ratio of the ACLR limb to the contralateral limb.
Change in peak internal knee extension moment during walking over the first 12 months following ACL reconstruction surgery
Time frame: Up to 12 months post ACL reconstruction surgery
Three-dimensional walking gait biomechanics will be obtained a via a 10-camera motion capture system interfaced with force plates embedded in a walkway. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee extension moment will be identified during the first 50% of stance. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
Change in vertical ground reaction force instantaneous loading rate over the first 12 months following ACL reconstruction surgery
Time frame: Up to 12 months post ACL reconstruction surgery
The vertical ground reaction force will be sampled from force plates embedded in a walkway during walking gait biomechanics. The instantaneous loading rate during the first 50% of stance will be calculated as the first time derivative of the force vs. time curve and normalized to body weight. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
Change in KOOS Knee-related Quality of Life Subscale over the first 12 months following ACL reconstruction surgery
Time frame: Up to 12 months post ACL reconstruction surgery
The Knee Injury and Osteoarthritis Outcome Score (KOOS) survey will be administered electronically at all study visits. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery
Time frame: Up to 12 months post ACL reconstruction surgery
T1rho MRIs will be obtained to assess composition (i.e. proteoglycan concentration) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
Probability of attaining 90% single-leg hop symmetry at 12 months post-ACLR.
Time frame: Up to 12 months post ACL reconstruction surgery
Single-leg hop for distance will be assessed 12 months post-ACLR in both limbs. Limb symmetry will be calculated as ACLR/Contralateral, and the number of patients who attain 90% symmetry will be compared between the rehabilitation arms.
Change in peak internal knee adduction moment during landing over the first 12 months following ACL reconstruction surgery
Time frame: Up to 12 months post ACL reconstruction surgery
Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee adduction moment will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.
Change in quadriceps muscle quality over the first 12 months following ACL reconstruction surgery
Time frame: Up to 12 months post ACL reconstruction surgery
MRI-based calculation of % contractile tissue in each component of the quadriceps muscle
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chapel Hill, North Carolina
Collaborators
Womack Army Medical Center
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 31, 2025 · Source of record for eligibility and locations