This trial is active, not recruiting.

Condition atrophy
Treatment mri
Sponsor New York University School of Medicine
Start date October 2015
End date October 2019
Trial size 10 participants
Trial identifier NCT02781623, 15-00985


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
An MRI will be conducted pre-operatively, 3 months post-operatively, and 1 year post-operatively.

Primary Outcomes

Cross-sectional area (CSA) calculations
time frame: 1 Year
Quadriceps muscle strength
time frame: One Year
Muscle Volume
time frame: One Year
Pain Level
time frame: One Year

Secondary Outcomes

Isokinetic Knee-Extension Strength Test
time frame: One year

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture
Principal investigator Kenneeth Egol, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.