NCT02887131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
Last Updated

September 5, 2016

Status Verified

August 1, 2016

Enrollment Period

1 year

First QC Date

February 29, 2012

Last Update Submit

September 2, 2016

Conditions

Subtalar ArthritisSubtalar Instability

Keywords

Subtalar arthritisSubtalar instability

Outcome Measures

Primary Outcomes (7)

  • Talocalcaneal angle

    baseline

  • Maximum exposed distance on superolateral surface of calcaneum

    baseline

  • Minimum distance between sustentaculum tali and talus posteromedial tubercle

    baseline

  • Maximum distance between sustentaculum tali and talus posteromedial tubercle

    baseline

  • Maximum anterolateral talocalcaneal distance

    baseline

  • Maximum posterolateral talocalcaneal distance

    baseline

  • Minimum posterolateral talocalcaneal distance

    baseline

Study Arms (3)

Healthy volunteers

EXPERIMENTAL
Other: Dynamic CT of the ankle

Arthritis

EXPERIMENTAL
Other: Dynamic CT of the ankle

Instability

EXPERIMENTAL
Other: Dynamic CT of the ankle

Interventions

Dynamic CT of the ankleOTHER

during inversion and eversion mouvement, with Aquilion One Toshiba scanner

ArthritisHealthy volunteersInstability

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital

Nancy, France, 54000, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2012

First Posted

September 2, 2016

Study Start

November 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

September 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)