Morphologic and Biomechanical Analysis of the Carpal Ligaments (EDLIS)

Central Hospital, Nancy, France

Status: Completed

Conditions: Wrist Injuries; Joint Instability

Treatments: Procedure: Arthrography; Device: Dynamic CT

Study type: Interventional

Funder types: Other

Identifiers

NCT02401568

2014-A00845-42

Details and patient eligibility

About

Compare various dynamic biomechanical markers (distances and angles) in the wrist during dynamic CT studies in three groups of patients: Normal subjects, with scapholunate instability and with other types of wrist instability.

Full description

Patients referred for the evaluation of wrist pain with CT arthrography will be eligible for inclusion. Patients will benefit from dynamic CT acquisitions before and after arthrography with three maneuvers: radio-ulnar deviation, clenching fist and dart throwing motion. Patients will also benefit from a wrist MR study on a 3 tesla scanner.

The morphology of the carpal ligaments will be evaluated on static imaging (MR and CT arthrograph) and on dynamic CT arthrography.

Distance and angular measurements will be obtained from dynamic CT studies using an appropriate post processing tool (4D-Ortho).

Data obtained with dynamic wrist evaluation will be correlated to ligament morphology, classical wrist instability criteria on conventional radiographs and with surgery (if available).

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical signs of wrist instability or wrist pain
• Previous medical examination
• Informed consent
• Must have a social security number

Exclusion criteria

• MR or CT contra-indications
• No prior surgery
• Pregnancy

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Normal subjects

Other group

Description:

No morphologic changes in carpal ligaments or clinical signs of wrist instability. Dynamic CT of the wrist will be performed before and after arthrography.

Treatment:

Device: Dynamic CT

Procedure: Arthrography

Wrist instability

Other group

Description:

Morphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography.

Treatment:

Device: Dynamic CT

Procedure: Arthrography