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

NCT04134962 | Completed

• 1 other identifier: 2017-A01178-45
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Surgery; Foot Surgery; 3D Imaging

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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

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

Interventions

3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment DIAGNOSTIC_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.

Ankel surgery group; control foot group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• Dr François Lintz: collaborator

Study Sites (1)

Clinique de L'Union

Saint-Jean, 31240, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 22, 2019
• Study Start: February 13, 2018
• Primary Completion: October 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 3, 2020

Record last verified: 2020-04

Locations

FR (1)