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Clinical Trials/NCT02781623
NCT02781623
Completed
Not Applicable

Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

NYU Langone Health1 site in 1 country13 target enrollmentOctober 2015
ConditionsAtrophy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrophy
Sponsor
NYU Langone Health
Enrollment
13
Locations
1
Primary Endpoint
Quadriceps muscle strength
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study will quantify and examine the extent to which the quadriceps femoris muscle group atrophies following tibial plateau fractures and the length of time that atrophy affects function. The study will also look at the effects of tibial plateau fractures on the quadriceps muscle and the effect this atrophy has on functional outcome. Quadriceps atrophy will be measured both clinically and by using MRI scans taken pre-operatively, 3 months post operatively, and 1 year post-operatively. The injured leg and the non-injured leg will be scanned in order for the non-injured leg to serve as the control. In this way muscle volume can be estimated from the muscle thickness at specific locations in the thigh. The muscle strength of the quadriceps will also be assessed at the 3 month and 1 year visit by measuring isokinetic knee-extension torque, and functional assessment questionnaires will be completed at each study visit.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
January 18, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All racial and ethnic groups
  • Diagnosis of tibial plateau fracture
  • Patients who opt for surgical treatment or non-operative treatment of their fracture
  • Patients who consent to undergoing 3 MRI scans
  • Patients who are willing to follow-up for a minimum of 52 weeks

Exclusion Criteria

  • Patients younger than 18 years old or older than 65
  • Patients who may be pregnant or may become pregnant in the 52 weeks following injury
  • Patients who have electric, magnetic, or mechanical devices currently implanted
  • Patients who have abnormal ECG results
  • Diagnosis of any additional lower extremity fractures other than tibial plateau
  • Patients who fit the definition of a vulnerable population

Outcomes

Primary Outcomes

Quadriceps muscle strength

Time Frame: One Year

This will be measured by the highest knee-extension torque over six repetitions for each leg.

Muscle Volume

Time Frame: One Year

This will be measured by the sum of the CSAs (Cross Sectional Areas) of each image times the thickness (10mm) and interslice gap (10mm) of each section

Cross-sectional area (CSA) calculations

Time Frame: 1 Year

From the axial images obtained from the MRI for each leg, outlines of each muscle in the quadriceps femoris muscle group will be traced and used to calculate.

Pain Level

Time Frame: One Year

This will be measured by the Short Musculoskeletal Function Assessment Questionnaire (SMFA)

Secondary Outcomes

  • Isokinetic Knee-Extension Strength Test(One year)

Study Sites (1)

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