Muscle Weakness and Post-traumatic Knee OA

Not Applicable

Completed

• Conditions: Meniscectomy
• Interventions: Behavioral: Quadriceps intensive strengthening; Behavioral: Standard rehabilitation

• Registration Number: NCT01879852
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-18
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-09
• Results First Submitted: 2014-09-04
• Results First Submitted QC: 2014-09-04
• Results First Posted: 2014-09-11
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

1. traumatic onset meniscal tear (i.e. specific mechanism of injury)
2. meniscectomy surgery performed within 12 months of index injury
3. meniscal tear confirmed at the time of surgery
4. subject anticipates living in close proximity to Gainesville for one year following surgery.

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Exclusion Criteria

1. bilateral injury
2. concomitant ligamentous injury
3. previous knee injury
4. articular cartilage defect > Grade II on Outerbridge scale
5. patellofemoral joint pain > 3/10 with activity
6. lower limb alignment > 5 degrees of valgus or varus
7. contraindication to an MR examination including: a pacemaker, metal implants which are not MR compatible, pregnancy and severe claustrophobia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Rehabilitation + Quadriceps intensive strengthening	Standard rehabilitation	The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Standard Rehabilitation	Standard rehabilitation	Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Standard Rehabilitation + Quadriceps intensive strengthening	Quadriceps intensive strengthening	The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.

Primary Outcome Measures

Name	Time	Method
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score	Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)	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.
Change in Tibial Articular Cartilage Volume	Baseline (pre-surgery) to 1 year post-surgery	A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume.

Secondary Outcome Measures

Name	Time	Method
Single Leg Forward Hop Index	7 weeks post-surgery (post-intervention)	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 \[(distance on the surgical side/distance on the non-surgical side) \*100\]
Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)	Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)	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.

Trial Locations

Locations (1)

UF & Shands Orthopaedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States