Clinical trial NCT02401568: Morphologic and Biomechanical Analysis of the Carpal Ligaments
Official title: Morphologic and Biomechanical Analysis of the Carpal Ligaments: a Kinematic Study on Dynamic Area Detector CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Instability
Wrist Injuries
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

Eligibility 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

Primary outcomes:
measure: scapholunate diastasis (mm)
timeFrame: 1 day
measure: Scapholunate angle
timeFrame: 1 day
measure: Lunocapitate angle
timeFrame: 1 day
measure: Posterior radio scaphoid angle
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CentralHNF
state: Lorraine
Study officials:
affiliation: Central Hospital, Nancy, France
name: Alain Blum, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.