Distal Tibio-fibular JointNCT01737125
Morphological Study of Distal Tibio-fibular Joint on MRI
An observational study of Distal Tibio-fibular Joint, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The distal tibio-fibular joint ( DTFJ) be an integral part of the ankle and its injury makes all the gravity, forecast and complexity of ankle fracture treatment. It's classically described and known by radiological point of view, but in static incidence and from anatomical studies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distal Tibio-fibular Joint
- What is being tested?
- Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2012to Jul 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Major subjects without ankle surgical antecedent
Who may be able to join
- major subjects
- without ankle surgical antecedent
- Subject having signed an enlightened consent
Who cannot join
- Subject in exclusion period
- Subject operated for the ankle,
- Impossibility to give an enlightened information
- Subject under protection of justice
- Under guardianship subject
- Patient refusing to participate in the study
Show all 9Show fewer
- Minor subject
- Pregnant or breast-feeding woman
- Claustrophobic patient
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Orthopédique et de Traumatologie, Hôpital de Hautepierre
Strasbourg, 67098
About this study
Official title: Morphological Study of Distal Tibio-fibular Joint by Static MRI, Dynamics of Movement and Effort in Spatial High Resolution. Clinical Implication
The distal tibio-fibular joint ( DTFJ) be an integral part of the ankle and its injury makes all the gravity, forecast and complexity of ankle fracture treatment. It's classically described and known by radiological point of view, but in static incidence and from anatomical studies. To our knowledge the dynamic dimension and its modelling is missing. Our study will use high spatial-resolution MRI acquisition to obtain the best possible definition of DTFJ but especially it will be associated with MRI acquisition in movement, using typical fast sequences " TrueFISP " and "FLASH" which will allow a precise modelling of joint physiological movements and biomechanics on healthy subjects by a not invasive method. This analysis will be made on a simple movement of flexion and extension, the other possible movements of the ankle being blocked what corresponds to the clinical situation of an osteosynthesis ankle immobilized in post-operative by a dynamic rehabilitation shoe Axmed ® It will be associated an"effort test " with the reproduction of subjected joint of a load with MRI joint movement control This test will be made with an ankle fixed to 90 ° of flexion what reproduces the post-operative clinical situationThe meditative data will be associated with an anatomical biomechanical study of ankles presenting a syndesmosis injury repaired according to the classic protocol using in our department, by comparing them with the data of the literature to optimize techniques repair of this joint. Indeed there is not gold standard surgical technique Main PurposeTo understand, observe, analyze and quantify the joint movement during a simple movement of ankle extension and flexion, and during a simulation of axial load miming walk fixed to 90 ° as in post-operative. Secondary purpose - Modelling the DTFJ- Modify the post-operative care with hypothesis that load does not lead abnormal movement in DTFJ with an ankle fixed to 90 ° ( post-operative clinical condition). - Validate our technique of repair of this joint by comparing the data MRI with anatomical mechanical tests
- Conditions
- Distal Tibio-fibular Joint
- Being tested
- Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Radiation
- spatial high-resolution MRI multiplanar acquisition in T1 and T2 anatomical sequences
- MRI acquisition in movements with dynamic sequences BEAT-IRT ( dynamic TrueFISP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Tibio-fibular JointStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu EHLINGER, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737125
- Sponsor's protocol ID
- 5318
- Status last verified
- Jul 2013
- First submitted
- 26 Nov 2012
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Study of Distal Tibio-fibular Joint by Static MRI, Dynamics of Movement and Effort in Spatial High Resolution. Clinical Implication
- ClinicalTrials.gov ID
- NCT01737125
- Acronym / sponsor ID
- 5318
- Conditions
- Distal Tibio-fibular Joint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Nov 2012 (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 distal tibio-fibular joint ( DTFJ) be an integral part of the ankle and its injury makes all the gravity, forecast and complexity of ankle fracture treatment. It's classically described and known by radiological point of view, but in static incidence and from anatomical studies. To our knowledge the dynamic dimension and its modelling is missing. Our study will use high spatial-resolution MRI acquisition to obtain the best possible definition of DTFJ but especially it will be associated with MRI acquisition in movement, using typical fast sequences " TrueFISP " and "FLASH" which will allow a precise modelling of joint physiological movements and biomechanics on healthy subjects by a not invasive method. This analysis will be made on a simple movement of flexion and extension, the other possible movements of the ankle being blocked what corresponds to the clinical situation of an osteosynthesis ankle immobilized in post-operative by a dynamic rehabilitation shoe Axmed ® It will be associated an"effort test " with the reproduction of subjected joint of a load with MRI joint movement control This test will be made with an ankle fixed to 90 ° of flexion what reproduces the post-operative clinical situationThe meditative data will be associated with an anatomical biomechanical study of ankles presenting a syndesmosis injury repaired according to the classic protocol using in our department, by comparing them with the data of the literature to optimize techniques repair of this joint. Indeed there is not gold standard surgical technique Main PurposeTo understand, observe, analyze and quantify the joint movement during a simple movement of ankle extension and flexion, and during a simulation of axial load miming walk fixed to 90 ° as in post-operative. Secondary purpose - Modelling the DTFJ- Modify the post-operative care with hypothesis that load does not lead abnormal movement in DTFJ with an ankle fixed to 90 ° ( post-operative clinical condition). - Validate our technique of repair of this joint by comparing the data MRI with anatomical mechanical tests
Study design
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Major subjects without ankle surgical antecedent
Key inclusion criteria (3 listed)
- major subjects
- without ankle surgical antecedent
- Subject having signed an enlightened consent
Key exclusion criteria (9 listed)
- Subject in exclusion period
- Subject operated for the ankle,
- Impossibility to give an enlightened information
- Subject under protection of justice
- Under guardianship subject
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI)* spatial high-resolution MRI multiplanar acquisition in T1 and T2 anatomical sequences * MRI acquisition in movements with dynamic sequences BEAT-IRT ( dynamic TrueFISP) | Radiation | – |
Primary outcome
Not reported in the source record.
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 3 Jul 2013.
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.
Matthieu EHLINGER, MD principal investigator
Hôpitaux Universitaires de Strasbourg
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 Distal Tibio-fibular Joint, run by University Hospital, Strasbourg, 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 3 inclusion and 9 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 3 Jul 2013. 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.
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 3 Jul 2013.