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

Completed

• Conditions: Foot Surgery; Ankle Surgery; 3D Imaging
• Interventions: Diagnostic Test: 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment

• Registration Number: NCT04134962
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2018-02-13
• Primary Completion: 2018-10-31
• Study Completion: 2018-12-31
• Study First Submitted: 2019-10-03
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-22
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ankel surgery group	3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment	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.
control foot group	3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment	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

Primary Outcome Measures

Name	Time	Method
FAO sensitivity-specificiy	1 day	- Couples (Sensitivity - Specificity) of the FAO ROC curve allowing the morphological classification of the patients (Varus, Valgus or Normal)
FAO value measured	1 day	- 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.
FAO Reliability	1 day	- reliability of FAO measurement by the TALAS tools (Intraclass correlation coefficient)

Trial Locations

Locations (1)

Clinique de L'Union; 🇫🇷 Saint-Jean, France