Quantifying Quadriceps Atrophy Following Tibial Plateau Fracture

NCT ID: NCT02781623

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

13 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2022-01-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MRI

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

MRI

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kenneeth Egol, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

New York University Langone Medical Center

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-00985

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.