Actively Recruiting

Phase Not Applicable
Age: 16Years - 35Years
All Genders
NCT04875052

Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

Led by University of North Carolina, Chapel Hill · Updated on 2025-05-31

114

Participants Needed

2

Research Sites

289 weeks

Total Duration

On this page

Sponsors

U

University of North Carolina, Chapel Hill

Lead Sponsor

W

Womack Army Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

Who Can Participate

Age: 16Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 16 to 35 years
  • Unilateral, primary ACL reconstruction with bone-patellar tendon-bone autograft
Not Eligible

You will not qualify if you...

  • History of prior ACL injury or revision ACL reconstruction
  • History of prior knee surgery
  • Need for multiple ligament surgery at the time of ACL reconstruction
  • Injuries or surgeries at ACL reconstruction that delay early weight bearing (e.g., fractures, microfracture)
  • Removal of more than one-third of the medial or lateral meniscus during ACL reconstruction
  • Articular cartilage damage greater than grade 3A on the International Cartilage Repair Society scale at ACL reconstruction
  • Musculoskeletal injury to either leg within 3 months before participation other than the primary ACL injury
  • Prior diagnosis of radiographic osteoarthritis in any lower extremity joint
  • History of neurological disorders (e.g., stroke, multiple sclerosis)
  • Contraindications for MRI (e.g., claustrophobia, pacemaker, cochlear implant, metal foreign bodies, aneurysm clip)
  • Pregnant or planning pregnancy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

MOTION Science Institute

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

2

Womack Army Medical Center

Chapel Hill, North Carolina, United States, 27599

Not Yet Recruiting

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Research Team

T

Troy Blackburn, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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