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Completed

NCT Number: NCT02401568

Morphologic and Biomechanical Analysis of the Carpal Ligaments

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.

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Key information

Conditions

Joint Instability Arm Injuries Joint Diseases Musculoskeletal Diseases Wounds and Injuries Wrist Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CentralHNF

Nancy, Lorraine, 54000, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dynamic CT

Device

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).

Arthrography

Procedure

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

Primary outcomes

  1. scapholunate diastasis (mm)

    Time frame: 1 day

    The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed

  2. Scapholunate angle

    Time frame: 1 day

    the variation in the scapholunate angle during the maneuvers performed will be assessed

  3. Lunocapitate angle

    Time frame: 1 day

    the variation in the lunocapitate angle during the maneuvers performed will be assessed

  4. Posterior radio scaphoid angle

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: EDLIS

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2015
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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