NCT01737125

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 29, 2012

Completed
2 days until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

7 months

First QC Date

November 26, 2012

Last Update Submit

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Matthieu EHLINGER, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

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

Locations