Trials / Completed
CompletedNCT04134962
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 125 (actual)
- Sponsor
- Ramsay Générale de Santé · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-02-13
- Primary completion
- 2018-10-31
- Completion
- 2018-12-31
- First posted
- 2019-10-22
- Last updated
- 2020-04-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT04134962. Inclusion in this directory is not an endorsement.