Subtalar ArthritisIDISNCT02887131
Dynamic Imaging of the Subtalar Instability
A study testing Dynamic CT of the ankle in people with Subtalar Arthritis and Subtalar Instability, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subtalar Arthritis, Subtalar Instability
- What is being tested?
- Dynamic CT of the ankle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Nov 2012
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- unable to understand information about this study
- unable to understand the movement of inversion / eversion of ankle
- absence of affiliation to social security
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dynamic Computed Tomography Anatomy of Ankle in Inversion / Eversion Mouvement in Subtalar Instability.
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.
Read the detailed 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.
- Conditions
- Subtalar Arthritis, Subtalar Instability
- Being tested
- Dynamic CT of the ankle
- Keywords
- Subtalar arthritis, Subtalar instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic CT of the ankleOther
during inversion and eversion mouvement, with Aquilion One Toshiba scanner
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Not described Receives: Other: Dynamic CT of the ankle |
| Arthritis | Experimental | Not described Receives: Other: Dynamic CT of the ankle |
| Instability | Experimental | Not described Receives: Other: Dynamic CT of the ankle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Talocalcaneal angle
Measured: baseline
Maximum exposed distance on superolateral surface of calcaneum
Measured: baseline
Minimum distance between sustentaculum tali and talus posteromedial tubercle
Measured: baseline
Maximum distance between sustentaculum tali and talus posteromedial tubercle
Measured: baseline
Maximum anterolateral talocalcaneal distance
Measured: baseline
Maximum posterolateral talocalcaneal distance
Measured: baseline
Minimum posterolateral talocalcaneal distance
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subtalar ArthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887131
- Sponsor's protocol ID
- PSS 2011/IDIS-LUX/NK
- Acronym
- IDIS
- Status last verified
- Aug 2016
- First submitted
- 29 Feb 2012
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dynamic Computed Tomography Anatomy of Ankle in Inversion / Eversion Mouvement in Subtalar Instability.
- ClinicalTrials.gov ID
- NCT02887131
- Acronym / sponsor ID
- IDIS / PSS 2011/IDIS-LUX/NK
- Conditions
- Subtalar Arthritis, Subtalar Instability
- Keywords
- Subtalar arthritis, Subtalar instability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 2 Sep 2016 (estimated)
- 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.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Other: Dynamic CT of the ankle |
| Arthritis | Experimental | Other: Dynamic CT of the ankle |
| Instability | Experimental | Other: Dynamic CT of the ankle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- pregnancy
- unable to understand information about this study
- unable to understand the movement of inversion / eversion of ankle
- absence of affiliation to social security
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 |
|---|---|---|
| Dynamic CT of the ankleduring inversion and eversion mouvement, with Aquilion One Toshiba scanner | Other | Arthritis, Healthy volunteers, Instability |
Primary outcome
Talocalcaneal angle
Time frame: baseline
Maximum exposed distance on superolateral surface of calcaneum
Time frame: baseline
Minimum distance between sustentaculum tali and talus posteromedial tubercle
Time frame: baseline
Maximum distance between sustentaculum tali and talus posteromedial tubercle
Time frame: baseline
Maximum anterolateral talocalcaneal distance
Time frame: baseline
Maximum posterolateral talocalcaneal distance
Time frame: baseline
Minimum posterolateral talocalcaneal distance
Time frame: baseline
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 5 Sep 2016.
- Individual participant dataSharing planned: No
Related trials for Subtalar Arthritis
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Calcaneus Fracture
Active, not recruiting
Arthroscopic Versus Open Subtalar Arthrodesis for the Treatment of Subtalar Arthritis
Subtalar Arthritis
Not yet recruitingObservational study
Incidence of Subtalar Joint Fusion After Isolated Ankle Fusion
Ankle Arthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic CT of the ankle in people with Subtalar Arthritis and Subtalar Instability, run by Central Hospital, Nancy, France 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 6 inclusion and 4 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 5 Sep 2016. 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?
Talocalcaneal angle (time frame: baseline). The study lists 7 primary outcomes in all. 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 5 Sep 2016.