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Trial record 3 of 4 for:    Recruiting, Not yet recruiting, Available Studies | "Wrist Injuries"

Morphologic and Biomechanical Analysis of the Carpal Ligaments (EDLIS)

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ClinicalTrials.gov Identifier: NCT02401568
Recruitment Status : Recruiting
First Posted : March 30, 2015
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Joint Instability Wrist Injuries Device: Dynamic CT Procedure: Arthrography Not Applicable

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  (Clinical Trial)
Estimated 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 : February 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02401568


Contacts
Contact: Pedro Gondim Teixeira, MD, PhD 0033 3 83 85 21 61 ped_gt@hotmail.com
Contact: Anne Chanson, MD 0033 3 83 85 21 61 an.chanson@gmail.com

Locations
France
CentralHNF Recruiting
Nancy, Lorraine, France, 54000
Contact: Pedro Teixeira, MD, PhD    0033 3 83 85 21 61    ped_gt@hotmail.com   
Contact: Anne Chanson, MD    0033 3 83 85 21 61    an.chanson@gmail.com   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Study Director: Alain Blum, MD, PhD Central Hospital, Nancy, France