Computed Tomography for Evaluating Supination-external Rotation Type Ankle Fractures

October 2, 2019 updated by: John Marzo, State University of New York at Buffalo

Comparison of a Novel Weight Bearing Cone-beam Computed Tomography (CT) Scan to Gravity Stress X-ray for Determining Instability of Supination-external Rotation Type Ankle Fractures

To compare measures of ankle stability from an investigational cone beam computed tomography scanner to gravity stress X-ray in patients who have unstable supination-external rotation ankle fractures.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

9

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
    • New York
      • Buffalo, New York, United States, 14226
        • UBMD Orthopaedics & Sports Medicine

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

Sampling Method

Probability Sample

Study Population

Patients who have been diagnosed with unstable supination-external rotation type ankle fractures

Description

Inclusion Criteria:

  • willing & able to provide written informed consent
  • at least 18 years-old
  • have medial clear space measuring less than 5 mm with clinical suspicion of instability and would normally require a gravity stress X-ray

Exclusion Criteria:

  • pregnant (females)
  • prisoners
  • open fracture
  • clinical signs of foot deformity
  • previous foot trauma or surgery on the affected foot
  • significant osteoarthritis or pre-existing ligamentous instability or pain in the affected foot
  • unable to stand in the weight bearing position during the CT scan

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

Cohorts and Interventions

Group / Cohort
Ankle fracture cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medial Clear Space Distance in the Ankle Joint
Time Frame: Baseline- single-day study
measured on weight bearing CBCT
Baseline- single-day study

Secondary Outcome Measures

Outcome Measure
Time Frame
Medial Clear Space on Gravity Stress Xray
Time Frame: Baseline
Baseline
Medial Clear Space on Standard Xray
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

State University of New York at Buffalo

Investigators

  • Principal Investigator: John Marzo, MD, UBMB Orthopaedics & Sports Medicine

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

February 1, 2016

Primary Completion (Actual)

February 2, 2017

Study Completion (Actual)

February 2, 2017

Study Registration Dates

First Submitted

November 4, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (Estimate)

November 6, 2015

Study Record Updates

Last Update Posted (Actual)

October 25, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 733368-1

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.

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