Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

Completed

• Conditions: Atrophy
• Interventions: Procedure: MRI

• Registration Number: NCT02781623
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-24
• Primary Completion: 2022-01-18
• Study Completion: 2022-01-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-11
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Quadriceps muscle strength	One Year	This will be measured by the highest knee-extension torque over six repetitions for each leg.
Muscle Volume	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	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	One Year	This will be measured by the Short Musculoskeletal Function Assessment Questionnaire (SMFA)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

New York University Langone Medical Center; 🇺🇸 New York, New York, United States