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Muscle Weakness and Post-traumatic Knee OA

Primary Purpose

Meniscectomy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quadriceps intensive strengthening
Standard rehabilitation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meniscectomy focused on measuring Quadriceps strength, Knee, Rehabilitation

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UF & Shands Orthopaedics and Sports Medicine Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Rehabilitation

Standard Rehabilitation + Quadriceps intensive strengthening

Arm Description

Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.

The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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]
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.

Full Information

First Posted
June 13, 2013
Last Updated
September 17, 2014
Sponsor
University of Florida
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT01879852
Brief Title
Muscle Weakness and Post-traumatic Knee OA
Official Title
Muscle Weakness and Post-traumatic Knee OA
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscectomy
Keywords
Quadriceps strength, Knee, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Rehabilitation
Arm Type
Active Comparator
Arm Description
Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Arm Title
Standard Rehabilitation + Quadriceps intensive strengthening
Arm Type
Experimental
Arm Description
The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Intervention Type
Behavioral
Intervention Name(s)
Quadriceps intensive strengthening
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard rehabilitation
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score
Description
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.
Time Frame
Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)
Title
Change in Tibial Articular Cartilage Volume
Description
A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume.
Time Frame
Baseline (pre-surgery) to 1 year post-surgery
Secondary Outcome Measure Information:
Title
Single Leg Forward Hop Index
Description
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]
Time Frame
7 weeks post-surgery (post-intervention)
Title
Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)
Description
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.
Time Frame
Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terese Chmielewski, PT, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF & Shands Orthopaedics and Sports Medicine Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States

12. IPD Sharing Statement

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Muscle Weakness and Post-traumatic Knee OA

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