EDLIS: Morphologic and Biomechanical Analysis of the Carpal Ligaments

Sponsor

Central Hospital, Nancy, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT02401568

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Joint Instability Wrist Injuries	Device: Dynamic CT Procedure: Arthrography	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Feb 1, 2018

Anticipated Study Completion Date :

Feb 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Normal subjects No morphologic changes in carpal ligaments or clinical signs of wrist instability. Dynamic CT of the wrist will be performed before and after arthrography.	Device: Dynamic CT Various low dose CT acquisitions will be successively performed on the wrist to allow a four dimensional evaluation. The same type of acquisition will be performed during various manoeuvers (radio-ulnar deviation, clenching fist, and dart-throwing motion). Procedure: Arthrography percutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints
Other: Wrist instability Morphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography.	Device: Dynamic CT Various low dose CT acquisitions will be successively performed on the wrist to allow a four dimensional evaluation. The same type of acquisition will be performed during various manoeuvers (radio-ulnar deviation, clenching fist, and dart-throwing motion). Procedure: Arthrography percutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints

Arm

Intervention/Treatment

Other: Normal subjects

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

Device: Dynamic CT

Various low dose CT acquisitions will be successively performed on the wrist to allow a four dimensional evaluation. The same type of acquisition will be performed during various manoeuvers (radio-ulnar deviation, clenching fist, and dart-throwing motion).

Procedure: Arthrography

percutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints

Other: Wrist instability

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

Device: Dynamic CT

Procedure: Arthrography

percutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints

Outcome Measures

Primary Outcome Measures

scapholunate diastasis (mm) [1 day]
The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CentralHNF	Nancy	Lorraine	France	54000

Sponsors and Collaborators

Central Hospital, Nancy, France

Investigators

Study Director: Alain Blum, MD, PhD, Central Hospital, Nancy, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Central Hospital, Nancy, France

ClinicalTrials.gov Identifier:

NCT02401568

Other Study ID Numbers:

2014-A00845-42

First Posted:

Mar 30, 2015

Last Update Posted:

Mar 8, 2016

Last Verified:

Mar 1, 2016

Additional relevant MeSH terms:

Joint Instability

Wrist Injuries

Study Results

No Results Posted as of Mar 8, 2016