Muscle Weakness and Post-traumatic Knee OA

Study Overview
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Brief Summary
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This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of standard or quadriceps intensive rehabilitation. The objective of the study was to determine the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.

Official Title
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Muscle Weakness and Post-traumatic Knee OA

Conditions
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Meniscectomy

Intervention / Treatment
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* Behavioral: Quadriceps intensive strengthening
* Behavioral: Standard rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: traumatic onset meniscal tear (i.e. specific mechanism of injury) meniscectomy surgery performed within 12 months of index injury meniscal tear confirmed at the time of surgery subject anticipates living in close proximity to Gainesville for one year following surgery. Exclusion Criteria: bilateral injury concomitant ligamentous injury previous knee injury articular cartilage defect > Grade II on Outerbridge scale patellofemoral joint pain > 3/10 with activity lower limb alignment > 5 degrees of valgus or varus contraindication to an MR examination including: a pacemaker, metal implants which are not MR compatible, pregnancy and severe claustrophobia.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Rehabilitation<br>Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises. | Behavioral: Standard rehabilitation<br>* Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)<br>|
| Experimental: Standard Rehabilitation + Quadriceps intensive strengthening<br>The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol. | Behavioral: Quadriceps intensive strengthening<br>* Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.<br>Behavioral: Standard rehabilitation<br>* Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score | The IKDC is a measure of self-reported knee function and includes items related to symptoms and functional activity. Responses on the IKDC subjective knee form will be recorded on hard-copy and the summary score computed. The highest (best) possible score is 100 points and the lowest (worst) possible score is 0 points. | Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention) | 
| Change in Tibial Articular Cartilage Volume | A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume. | Baseline (pre-surgery) to 1 year post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single Leg Forward Hop Index | Three trials of the single leg forward hop will be collected on each side. Distance will be averaged across trials. The single leg hop index will be computed as [(distance on the surgical side/distance on the non-surgical side) *100] | 7 weeks post-surgery (post-intervention) | 
| Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II) | CTX-II is a biomarker of Type II collagen degradation. Early-morning, second void, fasting urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay, corrected for creatine concentration, and log-transformed. Creatinine concentration will also be determined with enzyme-linked immunosorbent assay. | Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quadriceps strength, Knee, Rehabilitation