Morphological Study of Distal Tibio-fibular Joint on MRI

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01737125
First received: November 26, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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 Intervention
Distal Tibio-fibular Joint
Radiation: Magnetic Resonance Imaging (MRI)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Strasbourg, France:

Enrollment: 15
Study Start Date: December 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: 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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Major subjects without ankle surgical antecedent

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737125

Locations
France
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
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01737125     History of Changes
Other Study ID Numbers: 5318
Study First Received: November 26, 2012
Last Updated: July 2, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

ClinicalTrials.gov processed this record on April 17, 2014