Dynamic Imaging of the Subtalar Instability (IDIS)

September 2, 2016 updated by: Central Hospital, Nancy, France

Evaluation of Dynamic Computed Tomography Anatomy of Ankle in Inversion / Eversion Mouvement in Subtalar Instability.

The purpose of this study is to describe normal dynamic computed tomography anatomy of hind foot in inversion/eversion movement, and to define diagnostic criteria for subtalar instability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dynamic CT (Aquilion One Toshiba) of the ankle during inversion and eversion movement will be performed in patients from three groups: healthy volunteers, patients with subtalar arthritis, and patients with suspicion of subtalar instability.

Study Type

Interventional

Enrollment (Actual)

60

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

  • France
      • Nancy, France, 54000
        • Central Hospital

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Group Instability: suspicion of subtalar instability
  • Group Arhtritis: subtalar stiffness
  • Group Healthy volunteers: healthy volunteers
  • conscious and cooperating
  • written consent obtained after oral and written clear and intelligible information
  • no pregnancy

Exclusion Criteria:

  • pregnancy
  • unable to understand information about this study
  • unable to understand the movement of inversion / eversion of ankle
  • absence of affiliation to social security

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Other: Dynamic CT of the ankle
during inversion and eversion mouvement, with Aquilion One Toshiba scanner
Experimental: Arthritis
Other: Dynamic CT of the ankle
during inversion and eversion mouvement, with Aquilion One Toshiba scanner
Experimental: Instability
Other: Dynamic CT of the ankle
during inversion and eversion mouvement, with Aquilion One Toshiba scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Talocalcaneal angle
Time Frame: baseline
baseline
Maximum exposed distance on superolateral surface of calcaneum
Time Frame: baseline
baseline
Minimum distance between sustentaculum tali and talus posteromedial tubercle
Time Frame: baseline
baseline
Maximum distance between sustentaculum tali and talus posteromedial tubercle
Time Frame: baseline
baseline
Maximum anterolateral talocalcaneal distance
Time Frame: baseline
baseline
Maximum posterolateral talocalcaneal distance
Time Frame: baseline
baseline
Minimum posterolateral talocalcaneal distance
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

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

November 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 29, 2012

First Submitted That Met QC Criteria

August 29, 2016

First Posted (Estimate)

September 2, 2016

Study Record Updates

Last Update Posted (Estimate)

September 5, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS 2011/IDIS-LUX/NK

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.

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