RECRUITING

Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

The Effects of Vibratory Stimuli on Joint Health and Post-traumatic Osteoarthritis Risk Following Anterior Cruciate Ligament Injury

Quick Facts

Study Start:2021-01-11

Study Completion:2025-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04875052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Age 16 to 35 years * Unilateral, primary ACLR with bone-patellar tendon-bone autograft	* 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

Inclusion Criteria

Exclusion Criteria

* Age 16 to 35 years
* Unilateral, primary ACLR with bone-patellar tendon-bone autograft

* 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

Contacts and Locations

Study Contact

Troy Blackburn, PhD

CONTACT

919-843-2021

troyb@email.unc.edu

Principal Investigator

Troy Blackburn, PhD

PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Study Locations (Sites)

MOTION Science Institute

Chapel Hill, North Carolina, 27599

United States

Womack Army Medical Center

Chapel Hill, North Carolina, 27599

United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

Troy Blackburn, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-11

Study Completion Date2025-02

Study Record Updates

Study Start Date2021-01-11

Study Completion Date2025-02

Terms related to this study

Additional Relevant MeSH Terms

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