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Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781623
First Posted: May 24, 2016
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
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.

Condition Intervention
Atrophy Procedure: MRI

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.

  • 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

  • Pain Level [ Time Frame: One Year ]
    This will be measured by the Short Musculoskeletal Function Assessment Questionnaire (SMFA)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 10
Study Start Date: October 2015
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MRI
An MRI will be conducted pre-operatively, 3 months post-operatively, and 1 year post-operatively.
Procedure: MRI

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who opt for surgical treatment or non-operative treatment of their fracture.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781623


Locations
United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Kenneeth Egol, MD New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02781623     History of Changes
Other Study ID Numbers: 15-00985
First Submitted: May 20, 2016
First Posted: May 24, 2016
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by New York University School of Medicine:
Quadriceps
Tibial Plateau
Fracture

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical