- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06655363
Anatomo-radiological Study of the Ankle's Lateral Ligament
October 23, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Saint-Priest-en-Jarez, France, 42270
- CHU de Saint-Etienne
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing routine follow-up MRI one year after ankle ligament surgery will be included.
Description
Inclusion Criteria:
- Adult patients with no history of sprain on studied ankle
Exclusion Criteria:
- Sprain on studied ankle
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Anatomical arm
|
Anatomical description of cervical ligament, calcaneo fibular ligament, interosseus talo-calcaneal ligament, talo-fibular ligament.
|
|
Radiological arm
|
Radiological (MRI) description of cervical ligament, calcaneo fibular ligament, interosseus talo-calcaneal ligament, talo-fibular ligament.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical ligament length
Time Frame: Day : 1
|
Anatomical description of cervical ligament, by length (mm).
|
Day : 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Calcaneo fibular ligament length
Time Frame: Day : 1
|
Anatomical description of calcaneo fibular ligament, by length (mm).
|
Day : 1
|
|
Cervical ligament width
Time Frame: Day : 1
|
Anatomical description of cervical ligament, by width (mm).
|
Day : 1
|
|
Calcaneo fibular ligament width
Time Frame: Day : 1
|
Anatomical description of calcaneo fibular ligament, by width (mm).
|
Day : 1
|
|
Calcaneo fibular ligament thickness
Time Frame: Day : 1
|
Anatomical description of cervical calcaneo fibular ligament, by thickness (mm).
|
Day : 1
|
|
Cervical ligament thickness
Time Frame: Day : 1
|
Anatomical description of cervical ligament, by thickness (mm).
|
Day : 1
|
|
Interosseus talo-calcaneal ligament length
Time Frame: Day : 1
|
Anatomical description of interosseus talo-calcaneal ligament, by length (mm).
|
Day : 1
|
|
Interosseus talo-calcaneal ligament width
Time Frame: Day : 1
|
Anatomical description of interosseus talo-calcaneal ligament, by width (mm).
|
Day : 1
|
|
Interosseus talo-calcaneal ligament thickness
Time Frame: Day : 1
|
Anatomical description of interosseus talo-calcaneal ligament, by thickness (mm).
|
Day : 1
|
|
Talo-fibular ligament length
Time Frame: Day : 1
|
Anatomical description of talo-fibular ligament, by length (mm).
|
Day : 1
|
|
Talo-fibular ligament width
Time Frame: Day : 1
|
Anatomical description of talo-fibular ligament, by width (mm).
|
Day : 1
|
|
Talo-fibular ligament thickness
Time Frame: Day : 1
|
Anatomical description of talo-fibular ligament, by thickness (mm).
|
Day : 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pierre-Henri VERMOREL, MD, CHU de Saint-Etienne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2024
Primary Completion (Actual)
October 11, 2024
Study Completion (Actual)
October 11, 2024
Study Registration Dates
First Submitted
October 22, 2024
First Submitted That Met QC Criteria
October 22, 2024
First Posted (Actual)
October 23, 2024
Study Record Updates
Last Update Posted (Actual)
October 26, 2024
Last Update Submitted That Met QC Criteria
October 23, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRBN762024/CHUSTE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.