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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02401568
Other study ID # 2014-A00845-42
Secondary ID
Status Recruiting
Phase N/A
First received March 11, 2015
Last updated March 7, 2016
Start date February 2015
Est. completion date February 2019

Study information

Verified date March 2016
Source Central Hospital, Nancy, France
Contact Pedro Gondim Teixeira, MD, PhD
Phone 0033 3 83 85 21 61
Email ped_gt@hotmail.com
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date February 2019
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CentralHNF Nancy Lorraine

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (4)

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 — View 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. — View 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 — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary scapholunate diastasis (mm) The distance between the scaphoid bone and the lunate bone will be measured during all maneuvers performed 1 day No
Primary Scapholunate angle the variation in the scapholunate angle during the maneuvers performed will be assessed 1 day No
Primary Lunocapitate angle the variation in the lunocapitate angle during the maneuvers performed will be assessed 1 day No
Primary 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 1 Day No
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