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Completed

NCT Number: NCT04134962

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

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.

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Key information

Conditions

Ankle Surgery 3D Imaging Foot Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique de L'Union

Saint-Jean, 31240, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. FAO value measured

    Time frame: 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.

  2. FAO Reliability

    Time frame: 1 day

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

  3. FAO sensitivity-specificiy

    Time frame: 1 day

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

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Dr François Lintz

Registry information

Official study title

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

Acronym: 3D-HAM

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 22, 2019
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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