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CompletedNCT041349623D-HAMUpdated Jul 16, 2026

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

An observational study in Ankle Surgery, Foot Surgery and 3D Imaging, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
125
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ankle Surgery
  • Foot Surgery
  • 3D Imaging
03

In context

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
125 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic test3D 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. FAO Reliability

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

    Time frame: 1 day

  3. 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

07

Study locations

1 site
  • Clinique de L'Union
    Saint-Jean, 31240, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04134962
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborators
Dr François Lintz
Responsible party
Sponsor
First posted
Oct 22, 2019
Start date
Feb 13, 2018
Primary completion
Oct 31, 2018
Completion
Dec 31, 2018
Last update
Jul 16, 2026

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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