Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-35
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 16 to 35 years

Unilateral, primary ACLR with bone-patellar tendon-bone autograft

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental: Whole Body Vibration

    Device

    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.

  • Experimental: Local Muscle Vibration

    Device

    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.

  • Standard ACL Rehabilitation

    Other intervention

    Patients will complete a standard of care rehabilitation emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control.

Treatment groups

114 Participants
are divided into 3 treatment groups
Group A: Standard ACL RehabilitationActive comparator 1 intervention
Group B: Whole Body VibrationExperimental treatment 1 intervention
Group C: Local Muscle VibrationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quadriceps Isometric Peak Torque Limb Symmetry Index over the first 12 months following 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.

Time frame
Up to 12 months post ACL reconstruction surgery
2

Change in peak internal knee extension moment during walking over the first 12 months following 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.

Time frame
Up to 12 months post ACL reconstruction surgery
3

Change in vertical ground reaction force instantaneous loading rate over the first 12 months following 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.

Time frame
Up to 12 months post ACL reconstruction surgery
4

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

Time frame
Up to 12 months post ACL reconstruction surgery

Secondary outcomes

1

Quadriceps Isometric Rate of Torque Development Limb Symmetry Index over the first 12 months following 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. Rate of torque development will be calculated as the slope of the torque vs. time curve from 20-80% peak torque and normalized to body mass. The limb symmetry index will be calculated as the ratio of the ACLR limb to the contralateral limb.

Time frame
Up to 12 months post ACL reconstruction surgery
2

Change in peak internal knee abduction moment over the first 12 months following 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 abduction 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.

Time frame
Up to 12 months post ACL reconstruction surgery
3

Change in internal knee extension moment impulse over the first 12 months following 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 impulse 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.

Time frame
up to 12 months post ACL reconstruction surgery
4

Change in internal knee abduction moment impulse over the first 12 months following 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 abduction moment impulse 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.

Time frame
Up to 12 months post ACL reconstruction surgery

Other outcomes

Sponsors and contacts

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University of North Carolina, Chapel Hill

Lead sponsor

Womack Army Medical Center

Collaborator