Clinical trial NCT04875052: Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury
Official title: The Effects of Vibratory Stimuli on Joint Health and Post-traumatic Osteoarthritis Risk Following Anterior Cruciate Ligament Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Anterior Cruciate Ligament Injuries
Post-traumatic Osteoarthritis
Quadriceps Muscle Atrophy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Womack Army Medical Center
First posted: 2021-05-06
Enrollment: 114
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Background: Post-traumatic knee osteoarthritis (PTOA) is a leading cause of medical separation from military service. Anterior cruciate ligament (ACL) injury and surgical reconstruction (ACLR) incurs a high PTOA risk. Aberrant gait biomechanics contribute to PTOA development and are attributable to quadriceps muscle dysfunction. Additionally, up to 30% of patients experience secondary ACL injury. Aberrant landing biomechanics contribute to secondary ACL injury risk and are influenced by quadriceps dysfunction. Vibration acutely improves quadriceps function and gait biomechanics in individuals with ACLR, but its effects on joint health, PTOA risk, and landing biomechanics are unknown.

Hypothesis/Objective: This study will evaluate the effects of vibration embedded in ACLR rehabilitation on quadriceps function, gait biomechanics, landing biomechanics, patient self-report outcomes, return-to-physical-activity (RTPA) criteria, and MRI indicators of knee joint health. The central hypothesis is that vibration will enhance gait and landing biomechanics consistent with reduced PTOA and secondary ACL injury risks, respectively, and that whole body vibration (WBV) delivered by a commercial device and local muscle vibration (LMV) delivered by a prototype device will produce equivalent improvements in the study outcomes. The rationale for the hypothesis is that vibration will more effectively improve quadriceps function compared to standard rehabilitation, thus restoring normal biomechanics and mitigating declines in joint health.

Specific Aim 1: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation (WBV and LMV) on quadriceps function. The investigators hypothesize that Vibration will produce superior outcomes (e.g. strength) compared to Standard rehabilitation, but that WBV and LMV will produce similar outcomes.

Specific Aim 2: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation on gait biomechanics linked to PTOA development. The investigators hypothesize that Vibration will produce superior outcomes compared to Standard rehabilitation, but that WBV and LMV will produce similar outcomes.

Specific Aim 3: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation on patient self-report outcomes. The investigators hypothesize that Vibration will produce superior outcomes compared to Standard rehabilitation, but that WBV and LMV will produce similar outcomes.

Specific Aim 4: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation on MRI indicators of knee joint health. The investigators hypothesize that cartilage composition (e.g. collagen, water, and proteoglycan content) will be poorer and PTOA incidence (MOAKS score) will be higher in the Standard cohort compared to both Vibration cohorts, but that WBV and LMV will produce similar outcomes.

Specific Aim 5: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation on landing biomechanics linked to secondary ACL injury risk. The investigators hypothesize that Vibration will produce superior outcomes compared to Standard rehabilitation, but that WBV and LMV will produce similar outcomes.

Specific Aim 6: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation on the probability of meeting evidence-based RTPA criteria (e.g. single-leg hop symmetry ≥90%). The investigators hypothesize that Vibration will display result in greater probabilities of meeting RTPA criteria compared to Standard rehabilitation at 6 months and 1 year post-ACLR, but that WBV and LMV will produce similar outcomes.

Specific Aim 7: To evaluate changes in quadriceps muscle quality over the first year following ACLR reconstruction surgery. The investigators hypothesize that quadriceps muscle quality will decline at 1, 6 and 12 months post-ACLR compared to preoperative measurements and that these changes will be more pronounced in the ACLR limb compared to the uninjured limb at 1, 6 and 12 months post-ACLR.

Specific Aim 8: To evaluate associations between changes in quadriceps muscle quality over the first year following ACLR. The investigators hypothesize that declines in muscle quality between preoperative and 1- and 6- months post-ACLR timepoints will be associated with lesser knee extensor strength, aberrant gait biomechanics, worse patient self-report and functional outcomes, and deleterious alterations in knee cartilage composition.

Specific Aim 9: To compare the effects of Standard rehabilitation vs. Vibration rehabilitation on quadriceps muscle quality. The investigators hypothesize that Vibration will produce superior outcomes compared to Standard rehabilitation, but that WBV and LMV will produce similar outcomes.

Study Design: The approach will be to recruit ACLR patients at the onset of rehabilitation and conduct a Phase II single-blind randomized controlled trial to compare the effects of standard ACLR rehabilitation (control) vs. standard rehabilitation that incorporates WBV or LMV on the study outcomes over the first year post-ACLR.

Impact: This study will evaluate the effects of a novel rehabilitation approach on factors related to the risks of PTOA and secondary ACL injury following ACLR. ACL injury risk is 10x greater in military personnel vs. civilians, and PTOA is a leading cause of medical separation from military service, degrades quality of life, increases the risks of several comorbidities (e.g. obesity), and is a primary contributor to years of life lost due to disability. Improving rehabilitation of knee injuries is paramount for maintaining the combat readiness of the armed forces and preserving the health and well-being of Service members and Veterans, as well as millions of Americans at risk of PTOA. Vibration represents a promising approach to this important challenge. Furthermore, in addition to being cost-effective, the portable nature of the prototype LMV device could have substantial implications for military personnel and US citizens, particularly those with limited access to rehabilitation facilities.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Quadriceps Isometric Peak Torque Limb Symmetry Index over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak internal knee extension moment during walking over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in vertical ground reaction force instantaneous loading rate over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in KOOS Knee-related Quality of Life Subscale over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Probability of attaining 90% single-leg hop symmetry at 12 months post-ACLR.
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak internal knee adduction moment during landing over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in quadriceps muscle quality over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
Secondary outcomes:
measure: Quadriceps Isometric Rate of Torque Development Limb Symmetry Index over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak internal knee abduction moment over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in internal knee extension moment impulse over the first 12 months following ACL reconstruction surgery
timeFrame: up to 12 months post ACL reconstruction surgery
measure: Change in internal knee abduction moment impulse over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak knee flexion angle over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak knee varus angle over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak vertical ground reaction force over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in preparatory quadriceps electromyographic (EMG) amplitude over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in weight acceptance quadriceps EMG amplitude over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in KOOS total score over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in IKDC total score over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in ACL-QOL total score over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in TSK-11 total score over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in Tegner Activity Scale total score over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in Marx Activity Rating Scale total score over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in T1rho relaxation time (lateral femoral condyle) over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in T1rho relaxation time (medial tibial condyle) over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in T1rho relaxation time (lateral tibial condyle) over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in T2 relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in T2 relaxation time (lateral femoral condyle) over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in T2 relaxation time (medial tibial condyle) over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in T2 relaxation time (lateral tibial condyle) over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: PTOA incidence 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Probability of attaining 90% quadriceps strength symmetry at 12 months post-ACLR.
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Probability of attaining 90% triple hop for distance symmetry at 12 months post-ACLR.
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Probability of attaining 90% crossover hop for distance symmetry at 12 months post-ACLR.
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak internal knee extension moment during landing over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak knee flexion angle during landing over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak knee valgus angle during landing over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in peak vertical ground reaction force during landing over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in preparatory quadriceps EMG amplitude during landing over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
measure: Change in preparatory hamstrings EMG amplitude during landing over the first 12 months following ACL reconstruction surgery
timeFrame: Up to 12 months post ACL reconstruction surgery
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: MOTION Science Institute
state: North Carolina
city: Chapel Hill
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Troy Blackburn, PhD
role: PRINCIPAL_INVESTIGATOR
References: