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Morphologic and Biomechanical Analysis of the Carpal Ligaments

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02401568
Acronym
EDLIS
Enrollment
200
Registered
2015-03-30
Start date
2015-02-28
Completion date
2021-05-31
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Joint Instability, Wrist Injuries

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.

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).

Interventions

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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* MR or CT contra-indications * No prior surgery * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
scapholunate diastasis (mm)1 dayThe distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed
Scapholunate angle1 daythe variation in the scapholunate angle during the maneuvers performed will be assessed
Lunocapitate angle1 daythe variation in the lunocapitate angle during the maneuvers performed will be assessed
Posterior radio scaphoid angle1 DayThe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026