Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

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.

Conditions

• Osteoarthritis, Knee
• Anterior Cruciate Ligament Injuries
• Post-traumatic Osteoarthritis
• Quadriceps Muscle Atrophy

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.

Sponsors & Collaborators

• Womack Army Medical Center

  collaborator FED

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Troy Blackburn, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-11

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Device

Yes

Countries

• United States

Study Locations