Morphological Study of Distal Tibio-fibular Joint on MRI
1 other identifier
observational
15
1 country
1
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedJuly 3, 2013
July 1, 2013
7 months
November 26, 2012
July 2, 2013
Conditions
Interventions
* spatial high-resolution MRI multiplanar acquisition in T1 and T2 anatomical sequences * MRI acquisition in movements with dynamic sequences BEAT-IRT ( dynamic TrueFISP)
Eligibility Criteria
Major subjects without ankle surgical antecedent
You may qualify if:
- major subjects
- without ankle surgical antecedent
- Subject having signed an enlightened consent
You may not qualify if:
- 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
- Minor subject
- Pregnant or breast-feeding woman
- Claustrophobic patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de Chirurgie Orthopédique et de Traumatologie, Hôpital de Hautepierre
Strasbourg, 67098, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthieu EHLINGER, MD
Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2012
First Posted
November 29, 2012
Study Start
December 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
July 3, 2013
Record last verified: 2013-07