Anatomo-radiological Study of the Ankle's Lateral Ligament | NCT06655363

Studies
Anatomo-radiological Study of the Ankle's Lateral Ligament

NCT06655363

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Last Update Posted

Oct 26, 2024Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Ankle Injuries and Disorders

Interventions

Anatomical description
Radiological (MRI) description

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 2024Actual

Primary Completion Date

Oct 11, 2024Actual

Completion Date

Oct 11, 2024Actual

First Submitted Date

Oct 22, 2024

First Submission Date that Met QC Criteria

Oct 22, 2024

First Posted Date

Oct 23, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2024

Last Update Posted Date

Oct 26, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Subtalar instability is found in 30% of cases following a severe ankle sprain. Treatment is conditioned by subtalar involvement, so detection is essential. There is no consensus on the ligament anatomy of the subtalar region, making precise diagnosis of subtalar ligament damage difficult. The aim of this study is to provide a detailed description of the anatomy of the subtalar ligaments of interest, followed by a detailed radiological description (MRI).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anatomical arm			Other: Anatomical description
Radiological arm			Other: Radiological (MRI) description

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anatomical description	Other	Anatomical description of cervical ligament, calcaneo fibular ligament, interosseus talo-calcaneal ligament, talo-fibular ligament.	Anatomical arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cervical ligament length	Anatomical description of cervical ligament, by length (mm).	Day : 1

Secondary Outcomes

Measure	Description	Time Frame
Calcaneo fibular ligament length	Anatomical description of calcaneo fibular ligament, by length (mm).	Day : 1
Cervical ligament width	Anatomical description of cervical ligament, by width (mm).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with no history of sprain on studied ankle

Exclusion Criteria:

Sprain on studied ankle

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing routine follow-up MRI one year after ankle ligament surgery will be included.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pierre-Henri VERMOREL, MD	CHU de Saint-Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Saint-Etienne		Saint-Priest-en-Jarez		42270	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016512	Ankle Injuries
D004194	Disease

Ancestor Terms

ID	Term
D007869	Leg Injuries
D014947	Wounds and Injuries
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009682	Magnetic Resonance Spectroscopy

Ancestor Terms

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided