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

Ramsay Générale de Santé

Status: Completed

Conditions: Foot Surgery; Ankle Surgery; 3D Imaging

Treatments: Diagnostic Test: 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment

Study type: Observational

Funder types: Other

Identifiers

NCT04134962

2017-A01178-45

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

125 participants in 2 patient groups

Ankel surgery group

Description:

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.

Treatment:

Diagnostic Test: 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment

control foot group

Description:

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

Treatment:

Diagnostic Test: 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment