Dynamic Imaging of the Subtalar Instability

Subtalar Arthritis Clinical Trial

— IDIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02887131
• Other study ID #: PSS 2011/IDIS-LUX/NK
• Status: Completed
• Phase: N/A
• First received: February 29, 2012
• Last updated: September 2, 2016
• Start date: November 2011
• Est. completion date: November 2012

Study information

• Verified date: August 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis
• Subtalar Arthritis
• Subtalar Instability

Intervention

Other:
• Dynamic CT of the ankle
during inversion and eversion mouvement, with Aquilion One Toshiba scanner

Locations

Country	Name	City	State
France	Central Hospital	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Talocalcaneal angle		baseline	No
Primary	Maximum exposed distance on superolateral surface of calcaneum		baseline	No
Primary	Minimum distance between sustentaculum tali and talus posteromedial tubercle		baseline	No
Primary	Maximum distance between sustentaculum tali and talus posteromedial tubercle		baseline	No
Primary	Maximum anterolateral talocalcaneal distance		baseline	No
Primary	Maximum posterolateral talocalcaneal distance		baseline	No
Primary	Minimum posterolateral talocalcaneal distance		baseline	No