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

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

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 Overview

• Status: Completed
• Conditions: Foot Surgery; Ankle Surgery; 3D Imaging
• Intervention / Treatment: Diagnostic test: 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment

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 Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• France
  • Saint-Jean, France, 31240
    • Clinique de l'Union

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult's 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: 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	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ramsay Générale de Santé
• Collaborators: Dr François Lintz

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2018
• Primary Completion (ACTUAL): October 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (ACTUAL): October 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017-A01178-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED