CLAP : Compare the Quality of 3D Modeling of the Wrist Based on the Cone Beam to the Gold Standard

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentre Hospitalier Universitaire de Besancon

About this trial

Recent advances in personalized 3D modeling make it possible to consider personalized hand modeling based on cone-beam CT. The goal is to develop a personalized 3D modeling tool for use in routine clinical practice that reduces both the radiation dose to which patients are currently exposed during CT scans and the time required to process CT data (segmentation). the main, objective of the study is to compare the quality of 3D hand modeling based on cone-beam CT with the gold standard of computed tomography.

This prospective, single-center, interventional study will include 6 healthy volunteers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

no clinical symptoms suggestive of a wrist ligament injury (e.g., pain, instability)

no contraindications to undergoing a CBCT scan (e.g., pregnancy, history of hypersensitivity to radiation).

Enrolled in or eligible for a French social security plan.

Signing of an informed consent form indicating that the subject understands the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and restrictions inherent to this study

Disqualifiers

Pregnant women and breastfeeding mothers

Persons deprived of their liberty by a judicial or administrative decision; persons undergoing involuntary psychiatric treatment; persons admitted to a health or social care facility for purposes other than research

Adults subject to a legal protection measure (judicial protection, guardianship, or conservatorship) or who are unable to give consent

Trial design

Design model

Single group

Treatments tested in this trial

  • wrist Cone-beam CT

    Other intervention

    Perfoming a wrist Cone-beam scan 7 days after study inclusion

  • wrist CT scan

    Other intervention

    Perfoming a wrist CT scan 22 days after study inclusion

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: wrist cone-beam CT and Ct scanExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

To Estimate the mean bias (mm) and 95% confidence intervals between cone-beam CT and the gold standard (CT)

To compare the quality of 3D hand modeling based on cone-beam CT with the gold standard of computed tomography.

Time frame
22 days after inclusion

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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