NCT06655363

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

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

September 6, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 22, 2024

Last Update Submit

October 23, 2024

Conditions

Ankle Injuries and Disorders

Keywords

AnkleSubtalar instabilityMRIAnatomy

Outcome Measures

Primary Outcomes (1)

  • Cervical ligament length

    Anatomical description of cervical ligament, by length (mm).

    Day : 1

Secondary Outcomes (11)

  • Calcaneo fibular ligament length

    Day : 1

  • Cervical ligament width

    Day : 1

  • Calcaneo fibular ligament width

    Day : 1

  • Calcaneo fibular ligament thickness

    Day : 1

  • Cervical ligament thickness

    Day : 1

  • +6 more secondary outcomes

Study Arms (2)

Anatomical arm

Other: Anatomical description

Radiological arm

Other: Radiological (MRI) description

Interventions

Anatomical descriptionOTHER

Anatomical description of cervical ligament, calcaneo fibular ligament, interosseus talo-calcaneal ligament, talo-fibular ligament.

Anatomical arm
Radiological (MRI) descriptionOTHER

Radiological (MRI) description of cervical ligament, calcaneo fibular ligament, interosseus talo-calcaneal ligament, talo-fibular ligament.

Radiological arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Adult patients with no history of sprain on studied ankle

You may not qualify if:

  • Sprain on studied ankle

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Ankle InjuriesDisease

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Pierre-Henri VERMOREL, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2024

First Posted

October 23, 2024

Study Start

September 6, 2024

Primary Completion

October 11, 2024

Study Completion

October 11, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)