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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04134962
Acronym
3D-HAM
Enrollment
125
Registered
2019-10-22
Start date
2018-02-13
Completion date
2018-12-31
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

3D Imaging, Ankle Surgery, Foot Surgery

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.

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.

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche
Lead SponsorOTHER
Dr François Lintz
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
FAO value measured1 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 Reliability1 day\- reliability of FAO measurement by the TALAS tools (Intraclass correlation coefficient)
FAO sensitivity-specificiy1 day\- Couples (Sensitivity - Specificity) of the FAO ROC curve allowing the morphological classification of the patients (Varus, Valgus or Normal)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026