Morphological Study of Distal Tibio-fibular Joint on MRI

July 2, 2013 updated by: University Hospital, Strasbourg, France

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

Study Overview

Status

Status

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Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67098
        • Service de Chirurgie Orthopédique et de Traumatologie, Hôpital de Hautepierre

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Major subjects without ankle surgical antecedent

Description

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

Study Plan

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How is the study designed?

Design Details

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Strasbourg, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthieu EHLINGER, MD, Hopitaux Universitaires de Strasbourg

Study record dates

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Study Major Dates

Study Start

Study Start

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December 1, 2012

Primary Completion (ACTUAL)

Primary Completion

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July 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5318

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