Morphologic and Biomechanical Analysis of the Carpal Ligaments

Not Applicable

• Conditions: Wrist Injuries; Joint Instability
• Interventions: Device: Dynamic CT; Procedure: Arthrography

• Registration Number: NCT02401568
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-27
• Study First Posted: 2015-03-30
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08
• Primary Completion: 2018-02
• Study Completion: 2019-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal subjects	Arthrography	No morphologic changes in carpal ligaments or clinical signs of wrist instability. Dynamic CT of the wrist will be performed before and after arthrography.
Normal subjects	Dynamic CT	No morphologic changes in carpal ligaments or clinical signs of wrist instability. Dynamic CT of the wrist will be performed before and after arthrography.
Wrist instability	Dynamic CT	Morphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography.
Wrist instability	Arthrography	Morphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography.

Primary Outcome Measures

Name	Time	Method
Posterior radio scaphoid angle	1 Day	The angle formed between the posterior most point of the scaphoid in the sagittal plane and the ventral and dorsal rims of the distal radius will be assessed
Scapholunate angle	1 day	the variation in the scapholunate angle during the maneuvers performed will be assessed
Lunocapitate angle	1 day	the variation in the lunocapitate angle during the maneuvers performed will be assessed
scapholunate diastasis (mm)	1 day	The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed

Trial Locations

Locations (1)

CentralHNF; 🇫🇷 Nancy, Lorraine, France