Morphological Study of Distal Tibio-fibular Joint on MRI

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT01737125
Collaborator
(none)
15
1
7
2.2

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Magnetic Resonance Imaging (MRI)

Study Design

Study Type:
Observational
Actual Enrollment :
15 participants
Observational Model:
Case-Only
Official Title:
Morphological Study of Distal Tibio-fibular Joint by Static MRI, Dynamics of Movement and Effort in Spatial High Resolution. Clinical Implication
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:
    • major subjects

    • without ankle surgical antecedent

    • Subject having signed an enlightened consent

    Exclusion criteria:
    • 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

    • Minor subject

    • Pregnant or breast-feeding woman

    • Claustrophobic patient

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Chirurgie Orthopédique et de Traumatologie, Hôpital de Hautepierre Strasbourg France 67098

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Matthieu EHLINGER, MD, Hôpitaux Universitaires de Strasbourg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT01737125
    Other Study ID Numbers:
    • 5318
    First Posted:
    Nov 29, 2012
    Last Update Posted:
    Jul 3, 2013
    Last Verified:
    Jul 1, 2013

    Study Results

    No Results Posted as of Jul 3, 2013