Lateral Versus Anterior Spanning External Fixator for Tibial Plateau Fractures

June 22, 2017 updated by: Brett Crist, University of Missouri-Columbia
The purpose of this study is to evaluate patients with tibial plateau fractures.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate patients with tibial plateau fractures. The goal is to compare the differences between anteriorly placed (front of leg) femoral external fixator pins and laterally placed (side of leg) femoral external fixator pins.

Specifically, we are evaluating how this placement affects the quadriceps muscle and knee function. The parameters that will be assessed are knee function, pain, and range of motion.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age and above (adult population)
  • All open and closed tibial plateau fractures

Exclusion Criteria:

  • 17 years of age and less (pediatric population)
  • Quadriplegic patients
  • Vascular Injury to Extremity
  • Ipsilateral femur fractures
  • Ipsilateral Hip fractures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Anterior pin placement
Device: Anterior pin placement
Anteriorly-placed (front of the leg) femoral external fixator pins
EXPERIMENTAL: Lateral pin placement
Device: Lateral pin placement
Laterally-placed (side of the leg) femoral external fixator pind

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quadriceps Strength
Time Frame: (admission, 6 weeks, 3 months, 6 months) 1 year
measurement of quadriceps muscle strength at final followup = 1 year data at interim time points recorded, but only final reported for this purpose
(admission, 6 weeks, 3 months, 6 months) 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Missouri-Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

January 25, 2008

First Submitted That Met QC Criteria

February 7, 2008

First Posted (ESTIMATE)

February 8, 2008

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 1059937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe