Morphologic and Biomechanical Analysis of the Carpal Ligaments

NCT ID: NCT02401568

Last Updated: 2025-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2021-05-31

Brief Summary

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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

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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).

Conditions

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Joint Instability Wrist Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Dynamic CT

Intervention Type DEVICE

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).

Arthrography

Intervention Type PROCEDURE

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.

Group Type OTHER

Dynamic CT

Intervention Type DEVICE

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).

Arthrography

Intervention Type PROCEDURE

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

Interventions

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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).

Intervention Type DEVICE

Arthrography

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alain Blum, MD, PhD

Role: STUDY_DIRECTOR

Central Hospital, Nancy, France

Locations

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CentralHNF

Nancy, Lorraine, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 25656096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23571486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22137722 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23863544 (View on PubMed)

Orkut S, Gillet R, Granero J, Hossu G, Douis N, Athlani L, Blum A, Gondim Teixeira PA. Assessment of Scapholunate Instability on 4D CT Scans in Patients with Inconclusive Conventional Images. Radiology. 2023 Sep;308(3):e230193. doi: 10.1148/radiol.230193.

Reference Type DERIVED
PMID: 37698480 (View on PubMed)

Other Identifiers

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2014-A00845-42

Identifier Type: -

Identifier Source: org_study_id

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