Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

November 11, 2022 updated by: NYU Langone Health
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who opt for surgical treatment or non-operative treatment of their fracture.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MRI
An MRI will be conducted pre-operatively, 3 months post-operatively, and 1 year post-operatively.
Procedure: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 Year
Quadriceps muscle strength
Time Frame: One Year
This will be measured by the highest knee-extension torque over six repetitions for each leg.
One Year
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
One Year
Pain Level
Time Frame: One Year
This will be measured by the Short Musculoskeletal Function Assessment Questionnaire (SMFA)
One Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isokinetic Knee-Extension Strength Test
Time Frame: One year
This test will be conducted on both legs to compare the physical strength of the injured leg with the non-injured leg.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Kenneeth Egol, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

January 18, 2022

Study Completion (ACTUAL)

January 18, 2022

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (ESTIMATE)

May 24, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 11, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-00985

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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