search
Back to results

Dynamic Imaging of the Subtalar Instability (IDIS)

Primary Purpose

Subtalar Arthritis, Subtalar Instability

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dynamic CT of the ankle
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Subtalar Arthritis focused on measuring Subtalar arthritis, Subtalar instability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Healthy volunteers

Arthritis

Instability

Arm Description

Outcomes

Primary Outcome Measures

Talocalcaneal angle
Maximum exposed distance on superolateral surface of calcaneum
Minimum distance between sustentaculum tali and talus posteromedial tubercle
Maximum distance between sustentaculum tali and talus posteromedial tubercle
Maximum anterolateral talocalcaneal distance
Maximum posterolateral talocalcaneal distance
Minimum posterolateral talocalcaneal distance

Secondary Outcome Measures

Full Information

First Posted
February 29, 2012
Last Updated
September 2, 2016
Sponsor
Central Hospital, Nancy, France
search

1. Study Identification

Unique Protocol Identification Number
NCT02887131
Brief Title
Dynamic Imaging of the Subtalar Instability
Acronym
IDIS
Official Title
Evaluation of Dynamic Computed Tomography Anatomy of Ankle in Inversion / Eversion Mouvement in Subtalar Instability.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subtalar Arthritis, Subtalar Instability
Keywords
Subtalar arthritis, Subtalar instability

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Title
Arthritis
Arm Type
Experimental
Arm Title
Instability
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Dynamic CT of the ankle
Intervention Description
during inversion and eversion mouvement, with Aquilion One Toshiba scanner
Primary Outcome Measure Information:
Title
Talocalcaneal angle
Time Frame
baseline
Title
Maximum exposed distance on superolateral surface of calcaneum
Time Frame
baseline
Title
Minimum distance between sustentaculum tali and talus posteromedial tubercle
Time Frame
baseline
Title
Maximum distance between sustentaculum tali and talus posteromedial tubercle
Time Frame
baseline
Title
Maximum anterolateral talocalcaneal distance
Time Frame
baseline
Title
Maximum posterolateral talocalcaneal distance
Time Frame
baseline
Title
Minimum posterolateral talocalcaneal distance
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Central Hospital
City
Nancy
ZIP/Postal Code
54000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Dynamic Imaging of the Subtalar Instability

We'll reach out to this number within 24 hrs