Muscle Weakness and Post-traumatic Knee OA

Meniscectomy Clinical Trial

Official title:

Muscle Weakness and Post-traumatic Knee OA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879852
• Other study ID #: 00060374
• Secondary ID: K01HD052713
• Status: Completed
• Phase: N/A
• First received: June 13, 2013
• Last updated: September 17, 2014
• Start date: October 2008
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 35 Years

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meniscectomy
• Muscle Weakness
• Paresis

Intervention

Behavioral:
• Quadriceps intensive strengthening
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.
• Standard rehabilitation
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)

Locations

Country	Name	City	State
United States	UF & Shands Orthopaedics and Sports Medicine Institute	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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	No
Secondary	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)	No
Secondary	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)	No