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CompletedNCT02401568EDLISUpdated Jun 17, 2025

Morphologic and Biomechanical Analysis of the Carpal Ligaments

An interventional study of Dynamic CT and Arthrography in Joint Instability and Wrist Injuries, sponsored by Central Hospital, Nancy, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by Central Hospital, Nancy, France · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Joint Instability
  • Wrist Injuries
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical signs of wrist instability or wrist pain
  • Previous medical examination
  • Informed consent
  • Must have a social security number

Exclusion criteria

Exclusion Criteria:

  • MR or CT contra-indications
  • No prior surgery
  • Pregnancy
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • 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 · Procedure: Arthrography

  • 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

Interventions

  • DeviceDynamic 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).

  • ProcedureArthrography

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

05

What researchers measure

Primary outcomes

  1. scapholunate diastasis (mm)

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

    Time frame: 1 day

  2. Scapholunate angle

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

    Time frame: 1 day

  3. Lunocapitate angle

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

    Time frame: 1 day

  4. 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

    Time frame: 1 Day

06

Study locations

1 site
  • CentralHNF
    Nancy, Lorraine 54000, France
07

References and documents

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. PubMed 25656096 ↗
  • 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. PubMed 23571486 ↗
  • 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. PubMed 22137722 ↗
  • 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. PubMed 23863544 ↗
08

Registry details

Key details

Study ID
NCT02401568
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Mar 30, 2015
Start date
Feb 2015
Primary completion
Feb 2021
Completion
May 2021
Last update
Jun 17, 2025

Study contacts

Alain Blum, MD, PhD
study director · Central Hospital, Nancy, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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