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Completed

NCT Number: NCT02781623

Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

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.

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Key information

Conditions

Atrophy Fractures, Bone Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

New York University Langone Medical Center

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Procedure

Primary outcomes

  1. 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.

  2. Quadriceps muscle strength

    Time frame: One Year

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

  3. 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

  4. Pain Level

    Time frame: One Year

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
May 24, 2016
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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