Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

Atrophy Clinical Trial

Official title:

Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781623
• Other study ID #: 15-00985
• Status: Completed
• Start date: October 2015
• Est. completion date: January 18, 2022

Study information

• Verified date: November 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 18, 2022
• Est. primary completion date: January 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy

Intervention

Procedure:
• MRI

Locations

Country	Name	City	State
United States	New York University Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Quadriceps muscle strength	This will be measured by the highest knee-extension torque over six repetitions for each leg.	One Year
Primary	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
Primary	Pain Level	This will be measured by the Short Musculoskeletal Function Assessment Questionnaire (SMFA)	One Year
Secondary	Isokinetic Knee-Extension Strength Test	This test will be conducted on both legs to compare the physical strength of the injured leg with the non-injured leg.	One year