- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01737125
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
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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
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Strasbourg, France, 67098
- Service de Chirurgie Orthopédique et de Traumatologie, Hôpital de Hautepierre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Matthieu EHLINGER, MD, Hôpitaux Universitaires de Strasbourg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (ACTUAL)
July 1, 2013
Study Completion (ACTUAL)
July 1, 2013
Study Registration Dates
First Submitted
November 26, 2012
First Submitted That Met QC Criteria
November 28, 2012
First Posted (ESTIMATE)
November 29, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
July 3, 2013
Last Update Submitted That Met QC Criteria
July 2, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- 5318
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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