Ankle Surgery3D-HAMNCT04134962
Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D.
An observational study of Ankle Surgery and Foot Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Surgery, Foot Surgery, 3D Imaging
- What is being tested?
- 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult's 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D. 3D-HAM Study.
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.
Read the 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
- Ankle Surgery, Foot Surgery, 3D Imaging
- Being tested
- 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignmentDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Ankel surgery group | 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. Receives: Diagnostic Test: 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment | |
| control foot group | 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 Receives: Diagnostic Test: 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
FAO Reliability
- reliability of FAO measurement by the TALAS tools (Intraclass correlation coefficient)
Measured: 1 day
FAO sensitivity-specificiy
- Couples (Sensitivity - Specificity) of the FAO ROC curve allowing the morphological classification of the patients (Varus, Valgus or Normal)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start13 Feb 2018
- Primary completion31 Oct 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle SurgeryStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr François Lintz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134962
- Sponsor's protocol ID
- 2017-A01178-45
- Acronym
- 3D-HAM
- Status last verified
- Jul 2026
- First submitted
- 3 Oct 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D. 3D-HAM Study.
- ClinicalTrials.gov ID
- NCT04134962
- Acronym / sponsor ID
- 3D-HAM / 2017-A01178-45
- Conditions
- Ankle Surgery, Foot Surgery, 3D Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Dr François Lintz
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankel surgery group | – | Diagnostic Test: 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignmentAdult 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. |
| control foot group | – | Diagnostic Test: 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignmentAdult 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult's 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignmentThe 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. | Diagnostic test | Ankel surgery group, control foot group |
Primary outcome
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.
FAO Reliability
Time frame: 1 day
- reliability of FAO measurement by the TALAS tools (Intraclass correlation coefficient)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Surgery and Foot Surgery, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FAO value measured (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.