Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D.

Ramsay Générale de Santé125 enrolled

Overview

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.

The analysis of the alignment of the foot is fundamental in the management of pathologies of the foot and ankle. The advent of 3D imaging under load (Scanner Cone Beam), less radiant and more precise, requires the development and evaluation of new measurement tools. 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.

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Ankle Surgery Foot Surgery 3D Imaging

Interventions

3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignmentDIAGNOSTIC_TEST

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient selected for a preoperative assessment in foot or ankle surgery, or patient seen in follow-up consultation for which a Cone Beam under load is prescribed * Patient having been informed of this study and having given their consent * Patient over 18 years old * Unprotected adult Exclusion Criteria: * Patient with a contraindication to the Cone Beam under load * 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).

Locations (1)

Clinique de L'Union

Saint-Jean, France

Outcomes

Primary Outcomes

FAO value measured

\- FAO value measured using the TALAS tool on data collected by the Cone Beam under load (PedCat). For the descriptive study of the distribution within the different populations (varus/normal/valgus), the first measurement carried out will be represented.

Time frame: 1 day

FAO Reliability

\- reliability of FAO measurement by the TALAS tools (Intraclass correlation coefficient)

Time frame: 1 day

FAO sensitivity-specificiy

\- Couples (Sensitivity - Specificity) of the FAO ROC curve allowing the morphological classification of the patients (Varus, Valgus or Normal)

Time frame: 1 day

Data from ClinicalTrials.gov

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