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Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02781623
Enrollment
13
Registered
2016-05-24
Start date
2015-10-31
Completion date
2022-01-18
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrophy

Keywords

Quadriceps, Tibial Plateau, Fracture

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.

Interventions

PROCEDUREMRI

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cross-sectional area (CSA) calculations1 YearFrom 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.
Quadriceps muscle strengthOne YearThis will be measured by the highest knee-extension torque over six repetitions for each leg.
Muscle VolumeOne YearThis 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
Pain LevelOne YearThis will be measured by the Short Musculoskeletal Function Assessment Questionnaire (SMFA)

Secondary

MeasureTime frameDescription
Isokinetic Knee-Extension Strength TestOne yearThis test will be conducted on both legs to compare the physical strength of the injured leg with the non-injured leg.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026