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NCT Number: NCT01737125

Morphological Study of Distal Tibio-fibular Joint on MRI

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Chirurgie Orthopédique et de Traumatologie, Hôpital de Hautepierre

Strasbourg, 67098, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic resonance imaging (MRI)

Radiation
  • spatial high-resolution MRI multiplanar acquisition in T1 and T2 anatomical sequences
  • MRI acquisition in movements with dynamic sequences BEAT-IRT ( dynamic TrueFISP)

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Morphological Study of Distal Tibio-fibular Joint by Static MRI, Dynamics of Movement and Effort in Spatial High Resolution. Clinical Implication

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 29, 2012
Registry last updated
Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.