Vibration and Post-traumatic Osteoarthritis Risk Following ACL Injury

Study Purpose

Background: Post-traumatic knee osteoarthritis (PTOA) is a leading cause of medical separation from military service. Anterior cruciate ligament injury and surgical reconstruction (ACLR) incurs a high PTOA risk and is an ideal model for evaluating PTOA prevention strategies. Aberrant gait biomechanics are a primary contributor to PTOA development and are attributable in part to quadriceps muscle dysfunction. Vibration acutely improves quadriceps function and gait biomechanics in individuals with ACLR, but its effects on joint health and PTOA risk are unknown. Hypothesis/Objective: The objective of this study is to evaluate the effects of vibration embedded in ACLR rehabilitation on 1) quadriceps function, 2) gait biomechanics, 3) patient self-report outcomes, and 4) MRI indicators of knee joint health. The central hypothesis is that vibration will enhance gait biomechanics consistent with reduced PTOA risk 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 gait biomechanics and mitigating declines in joint health. Specific Aim 1: To compare the effects of Standard rehabilitation vs.#46; 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.#46; Vibration rehabilitation (WBV and LMV) 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.#46; Vibration rehabilitation (WBV and LMV) on patient self-report outcomes. The investigators hypothesize that Vibration will produce superior outcomes compared to Standard rehabilitation, but that the outcomes will be similar between the WBV and LMV cohorts. Specific Aim 4: To compare the effects of Standard rehabilitation vs.#46; Vibration rehabilitation (WBV and LMV) 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. 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.#46; standard rehabilitation that incorporates WBV or LMV on quadriceps function, gait biomechanics, patient self-report outcomes, cartilage composition, and PTOA incidence over the first year post-ACLR. Impact: The proposed work will evaluate the effects of a novel rehabilitation approach (vibration) for preventing PTOA. PTOA is a leading cause of medical separation from military service, degrades quality of life, increases the risks of several comorbidities (e.g. obesity, depression, cardiovascular disease), 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 who are 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. The proposed work represents the critical translational link between existing pre-clinical data and the clinical setting that is necessary to establish its efficacy and accelerate its development as a commercially available device.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 16 Years - 35 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04875052
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of North Carolina, Chapel Hill
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Troy Blackburn, PhD
Principal Investigator Affiliation University of North Carolina, Chapel Hill
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherU.S. Fed
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

Arms

Active Comparator: Standard ACL Rehabilitation

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.

Experimental: Whole Body Vibration

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.

Experimental: Local Muscle Vibration

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.

Interventions

Device: - Experimental: Whole Body Vibration

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.

Device: - Experimental: Local Muscle Vibration

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.

Other: - Standard ACL Rehabilitation

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

MOTION Science Institute, Chapel Hill, North Carolina

Status

Address

MOTION Science Institute

Chapel Hill, North Carolina, 27599

Site Contact

Troy Blackburn, PhD

[email protected]

919-843-2021