Morphologic and Biomechanical Analysis of the Carpal Ligaments (EDLIS)

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

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.

Study Overview

• Status: Completed
• Conditions: Wrist Injuries; Joint Instability
• Intervention / Treatment: Device: Dynamic CT; Procedure: Arthrography

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Nancy, Lorraine, France, 54000
      • CentralHNF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scapholunate diastasis (mm)	The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed	1 day
Scapholunate angle	the variation in the scapholunate angle during the maneuvers performed will be assessed	1 day
Lunocapitate angle	the variation in the lunocapitate angle during the maneuvers performed will be assessed	1 day
Posterior radio scaphoid angle	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	1 Day

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Gondim Teixeira PA, Gervaise A, Louis M, Lecocq S, Raymond A, Aptel S, Blum A. Musculoskeletal wide detector CT: principles, techniques and applications in clinical practice and research. Eur J Radiol. 2015 May;84(5):892-900. doi: 10.1016/j.ejrad.2014.12.033. Epub 2015 Jan 17.
• Garcia-Elias M, Alomar Serrallach X, Monill Serra J. Dart-throwing motion in patients with scapholunate instability: a dynamic four-dimensional computed tomography study. J Hand Surg Eur Vol. 2014 May;39(4):346-52. doi: 10.1177/1753193413484630. Epub 2013 Apr 8.
• Halpenny D, Courtney K, Torreggiani WC. Dynamic four-dimensional 320 section CT and carpal bone injury - a description of a novel technique to diagnose scapholunate instability. Clin Radiol. 2012 Feb;67(2):185-7. doi: 10.1016/j.crad.2011.10.002. Epub 2011 Dec 3. No abstract available.
• Troupis JM, Amis B. Four-dimensional computed tomography and trigger lunate syndrome. J Comput Assist Tomogr. 2013 Jul-Aug;37(4):639-43. doi: 10.1097/RCT.0b013e31828b68ec.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (Estimated): March 30, 2015

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Wounds and Injuries; Joint Diseases; Arm Injuries; Wrist Injuries; Joint Instability
• Other Study ID Numbers: 2014-A00845-42