Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

NCT04875052 | Recruiting DMC FDA Device

• 1 other identifier: 19-1250
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (8)

• 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.

  Up to 12 months post ACL reconstruction surgery

• 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.

  Up to 12 months post ACL reconstruction surgery

• 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.

  Up to 12 months post ACL reconstruction surgery

• 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.

  Up to 12 months post ACL reconstruction surgery

• Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery

  T1rho MRIs will be obtained to assess composition (i.e. proteoglycan concentration) of the knee cartilage. Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.

  Up to 12 months post ACL reconstruction surgery

• Probability of attaining 90% single-leg hop symmetry at 12 months post-ACLR.

  Single-leg hop for distance will be assessed 12 months post-ACLR in both limbs. Limb symmetry will be calculated as ACLR/Contralateral, and the number of patients who attain 90% symmetry will be compared between the rehabilitation arms.

  Up to 12 months post ACL reconstruction surgery

• Change in peak internal knee adduction moment during landing over the first 12 months following ACL reconstruction surgery

  Three-dimensional kinematics and kinetics will be obtained during double-leg landing a via a 10-camera motion capture system interfaced with embedded force plates. An inverse dynamics approach will be employed to derive net internal joint moments. The peak internal knee adduction moment will be identified during the loading phase of landing (initial ground contact to peak knee flexion). Change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months and used as dependent variables.

  Up to 12 months post ACL reconstruction surgery

• Change in quadriceps muscle quality over the first 12 months following ACL reconstruction surgery

  MRI-based calculation of % contractile tissue in each component of the quadriceps muscle

  Up to 12 months post ACL reconstruction surgery

Secondary Outcomes (32)

• Quadriceps Isometric Rate of Torque Development Limb Symmetry Index over the first 12 months following ACL reconstruction surgery

  Up to 12 months post ACL reconstruction surgery

• Change in peak internal knee abduction moment over the first 12 months following ACL reconstruction surgery

  Up to 12 months post ACL reconstruction surgery

• Change in internal knee extension moment impulse over the first 12 months following ACL reconstruction surgery

  up to 12 months post ACL reconstruction surgery

• Change in internal knee abduction moment impulse over the first 12 months following ACL reconstruction surgery

  Up to 12 months post ACL reconstruction surgery

• Change in peak knee flexion angle over the first 12 months following ACL reconstruction surgery

  Up to 12 months post ACL reconstruction surgery

Study Arms (3)

Standard ACL Rehabilitation

ACTIVE COMPARATOR

Patients will complete a 20-week supervised, progressive rehabilitation protocol directed by physical therapists at 1 of 3 participating clinics. While the specific rehabilitation exercises and techniques used for a given patient may vary depending on clinician preference/experience and patient responsiveness and progress, the general rehabilitation protocol will be standardized and follow current best practices emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control consistent with the Multicenter Orthopaedics Outcomes Network (MOON) rehabilitation protocol.

Other: Standard ACL Rehabilitation

Whole Body Vibration

EXPERIMENTAL

Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to whole body vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.

Device: Experimental: Whole Body Vibration

Local Muscle Vibration

EXPERIMENTAL

Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to local muscle vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.

Device: Experimental: Local Muscle Vibration

Interventions

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.

Also known as: Power Plate pro5 (71-P5R-3100)

Whole Body Vibration

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.

Also known as: Prototype device developed by PI

Local Muscle Vibration

Standard ACL Rehabilitation OTHER

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

Also known as: Usual care

Standard ACL Rehabilitation

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Womack Army Medical Center: collaborator

Study Sites (2)

MOTION Science Institute

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Womack Army Medical Center

Chapel Hill, North Carolina, 27599, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Troy Blackburn, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Troy Blackburn, PhD

CONTACT

919-843-2021; troyb@email.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 6, 2021
• Study Start: January 11, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: 9 to 36 months
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (2)