Ankle Injuries and DisordersNCT06655363
Anatomo-radiological Study of the Ankle's Lateral Ligament
An observational study of Ankle Injuries and Disorders, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Injuries and Disorders
- What is being tested?
- Anatomical description and Radiological (MRI) description
- How many people
- 19 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2024to 11 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing routine follow-up MRI one year after ankle ligament surgery will be included.
Who may be able to join
- Adult patients with no history of sprain on studied ankle
Who cannot join
- Sprain on studied ankle
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Ankle Injuries and Disorders
- Being tested
- Anatomical description, Radiological (MRI) description
- Keywords
- Ankle, Subtalar instability, MRI, Anatomy
- Medical subject headings
- Ankle Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical descriptionOther
Anatomical description of cervical ligament, calcaneo fibular ligament, interosseus talo-calcaneal ligament, talo-fibular ligament.
Radiological (MRI) descriptionOther
Radiological (MRI) description of cervical ligament, calcaneo fibular ligament, interosseus talo-calcaneal ligament, talo-fibular ligament.
| Study group | Role | What they receive |
|---|---|---|
| Anatomical arm | Not described Receives: Other: Anatomical description | |
| Radiological arm | Not described Receives: Other: Radiological (MRI) description |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical ligament length
Anatomical description of cervical ligament, by length (mm).
Measured: Day : 1
Secondary outcomes (11)
Calcaneo fibular ligament length
Anatomical description of calcaneo fibular ligament, by length (mm).
Measured: Day : 1
Cervical ligament width
Anatomical description of cervical ligament, by width (mm).
Measured: Day : 1
Calcaneo fibular ligament width
Anatomical description of calcaneo fibular ligament, by width (mm).
Measured: Day : 1
Calcaneo fibular ligament thickness
Anatomical description of cervical calcaneo fibular ligament, by thickness (mm).
Measured: Day : 1
Cervical ligament thickness
Anatomical description of cervical ligament, by thickness (mm).
Measured: Day : 1
Interosseus talo-calcaneal ligament length
Anatomical description of interosseus talo-calcaneal ligament, by length (mm).
Measured: Day : 1
Interosseus talo-calcaneal ligament width
Anatomical description of interosseus talo-calcaneal ligament, by width (mm).
Measured: Day : 1
Interosseus talo-calcaneal ligament thickness
Anatomical description of interosseus talo-calcaneal ligament, by thickness (mm).
Measured: Day : 1
Talo-fibular ligament length
Anatomical description of talo-fibular ligament, by length (mm).
Measured: Day : 1
Talo-fibular ligament width
Anatomical description of talo-fibular ligament, by width (mm).
Measured: Day : 1
Talo-fibular ligament thickness
Anatomical description of talo-fibular ligament, by thickness (mm).
Measured: Day : 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start6 Sep 2024
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Injuries and DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Henri VERMOREL, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06655363
- Sponsor's protocol ID
- IRBN762024/CHUSTE
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomo-radiological Study of the Ankle's Lateral Ligament
- ClinicalTrials.gov ID
- NCT06655363
- Acronym / sponsor ID
- IRBN762024/CHUSTE
- Conditions
- Ankle Injuries and Disorders
- Keywords
- Ankle, Subtalar instability, MRI, Anatomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anatomical arm | – | Other: Anatomical description |
| Radiological arm | – | Other: Radiological (MRI) description |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing routine follow-up MRI one year after ankle ligament surgery will be included.
Key inclusion criteria (1 listed)
- Adult patients with no history of sprain on studied ankle
Key exclusion criteria (1 listed)
- Sprain on studied ankle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomical descriptionAnatomical description of cervical ligament, calcaneo fibular ligament, interosseus talo-calcaneal ligament, talo-fibular ligament. | Other | Anatomical arm |
| Radiological (MRI) descriptionRadiological (MRI) description of cervical ligament, calcaneo fibular ligament, interosseus talo-calcaneal ligament, talo-fibular ligament. | Other | Radiological arm |
Primary outcome
Cervical ligament length
Time frame: Day : 1
Anatomical description of cervical ligament, by length (mm).
11 secondary outcomes
Calcaneo fibular ligament length
Time frame: Day : 1
Cervical ligament width
Time frame: Day : 1
Calcaneo fibular ligament width
Time frame: Day : 1
Calcaneo fibular ligament thickness
Time frame: Day : 1
Cervical ligament thickness
Time frame: Day : 1
Interosseus talo-calcaneal ligament length
Time frame: Day : 1
Interosseus talo-calcaneal ligament width
Time frame: Day : 1
Interosseus talo-calcaneal ligament thickness
Time frame: Day : 1
Talo-fibular ligament length
Time frame: Day : 1
Talo-fibular ligament width
Time frame: Day : 1
Talo-fibular ligament thickness
Time frame: Day : 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Henri VERMOREL, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Injuries and Disorders, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical ligament length (time frame: Day : 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.