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

Foot Surgery Clinical Trial

— 3D-HAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04134962
• Other study ID #: 2017-A01178-45
• Status: Completed
• Start date: February 13, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: April 2020
• Source: Ramsay Générale de Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• 3D Imaging
• Ankle Surgery
• Foot Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Clinique de L'Union	Saint-Jean

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	Dr François Lintz

Country where clinical trial is conducted

France, 

Outcome

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