Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D.
NCT ID: NCT04134962
Last Updated: 2020-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
125 participants
OBSERVATIONAL
2018-02-13
2018-12-31
Brief Summary
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Detailed Description
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The automated TALAS measurement tool, working with the Cone Beam 3D scanner under load, provides a reproducible measurement of the Foot Ankle Offset (FAO). It is possible to determine an average value and the standard deviation of FAO in the relevant population. And to differentiate significantly the populations with a neutral alignment, varus or valgus.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ankel surgery group
Adult patients for which a Cone Beam under load is prescribed for a preoperative assessment of a foot or ankle surgery or for a follow-up consultation.
3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment
The Cone Beam under load is used for the diagnosis and monitoring of the foot and ankle. It has a CE marking for this purpose.
The images obtained by the Cone Beam under load (Ped Cat) will be analysed using the TALAS mathematical algorithm tool to measure the FAO.
The internal software of the Cone Beam under load will also be used to obtain a "radiographic" image corresponding to a 2D projection on which the tibio-calcaneal angle can be measured.
control foot group
Adult patients for which a Cone Beam under load is prescribed for a preoperative assessment of a foot or ankle surgery or for a follow-up consultation.
Will be retained only results of normal aligment FAO
3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment
The Cone Beam under load is used for the diagnosis and monitoring of the foot and ankle. It has a CE marking for this purpose.
The images obtained by the Cone Beam under load (Ped Cat) will be analysed using the TALAS mathematical algorithm tool to measure the FAO.
The internal software of the Cone Beam under load will also be used to obtain a "radiographic" image corresponding to a 2D projection on which the tibio-calcaneal angle can be measured.
Interventions
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3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment
The Cone Beam under load is used for the diagnosis and monitoring of the foot and ankle. It has a CE marking for this purpose.
The images obtained by the Cone Beam under load (Ped Cat) will be analysed using the TALAS mathematical algorithm tool to measure the FAO.
The internal software of the Cone Beam under load will also be used to obtain a "radiographic" image corresponding to a 2D projection on which the tibio-calcaneal angle can be measured.
Eligibility Criteria
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Inclusion Criteria
* Patient having been informed of this study and having given their consent
* Patient over 18 years old
* Unprotected adult
Exclusion Criteria
* Patient refusing to participate in this study
* Non-plantigrade foot under load (impossibility of simultaneously resting M1, M5 and Calcaneus on the ground)
* Patient who has already participated in the 3D HAM study (patients who would have participated in the study during the preoperative consultation for which another Cone Beam would be prescribed during the follow-up consultation. These patients would not be able to participate again in this study).
18 Years
ALL
No
Sponsors
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Dr François Lintz
UNKNOWN
Ramsay Générale de Santé
OTHER
Responsible Party
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Locations
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Clinique de L'Union
Saint-Jean, , France
Countries
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Other Identifiers
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2017-A01178-45
Identifier Type: -
Identifier Source: org_study_id
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