Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

NCT02781623 | Completed

• 1 other identifier: 15-00985
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrophy

Keywords

Quadriceps; Tibial Plateau; Fracture

Outcome Measures

Primary Outcomes (4)

• Cross-sectional area (CSA) calculations

  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

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

  One Year

• Muscle Volume

  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

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

  One Year

Secondary Outcomes (1)

• Isokinetic Knee-Extension Strength Test

  One year

Study Arms (1)

MRI

An MRI will be conducted pre-operatively, 3 months post-operatively, and 1 year post-operatively.

Procedure: MRI

Interventions

MRI PROCEDURE

MRI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Atrophy; Fractures, Bone

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Kenneeth Egol, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 24, 2016
• Study Start: October 1, 2015
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

US (1)