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NCT04875052 · ClinicalTrials.gov registry record · NA
Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury
A NA study of Osteoarthritis, Knee and Anterior Cruciate Ligament Injuries, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 114
- Enrollment target
- 2
- Study locations
NCT04875052: Recruiting NA study of Osteoarthritis, Knee and Anterior Cruciate Ligament Injuries, sponsored by University of North Carolina, Chapel Hill.
NCT04875052 is a NA study of Osteoarthritis, Knee and Anterior Cruciate Ligament Injuries that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 114 participants, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04875052, a NA study of Osteoarthritis, Knee and Anterior Cruciate Ligament Injuries, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 114 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Experimental: Whole Body Vibration
- DEVICE Experimental: Local Muscle Vibration
- OTHER Standard ACL Rehabilitation
Study Locations (2)
North Carolina
- MOTION Science Institute - Chapel Hill
- Womack Army Medical Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2021-01-11 |
| Est. Completion | 2026-08 |
| Phase | NA |
What NCT04875052 shows while recruiting
NCT04875052 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 497-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 3 interventions - of which Experimental: Whole Body Vibration is the first listed.
NCT04875052 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04875052 about?
NCT04875052 is a clinical study titled "Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury". 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). T...
What is the current status of trial NCT04875052?
This trial is currently recruiting. It is a NA study. The enrollment target is 114 participants. The study started on 2021-01-11. Estimated completion is 2026-08.
What conditions does trial NCT04875052 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Anterior Cruciate Ligament Injuries, Post-traumatic Osteoarthritis, Quadriceps Muscle Atrophy.
What interventions are being tested in trial NCT04875052?
The interventions under investigation include: Experimental: Whole Body Vibration (DEVICE), Experimental: Local Muscle Vibration (DEVICE), Standard ACL Rehabilitation (OTHER).
Who is sponsoring clinical trial NCT04875052?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04875052 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04875052's enrollment target sits among peer trials
114 60th of 112 higher than 52 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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