NCT02401568

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

June 17, 2025

Status Verified

July 1, 2020

Enrollment Period

6 years

First QC Date

March 11, 2015

Last Update Submit

June 13, 2025

Conditions

Joint InstabilityWrist Injuries

Outcome Measures

Primary Outcomes (4)

  • scapholunate diastasis (mm)

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

    1 day

  • Scapholunate angle

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

    1 day

  • Lunocapitate angle

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

    1 day

  • 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

Study Arms (2)

Normal subjects

OTHER

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 CTProcedure: Arthrography

Wrist instability

OTHER

Morphologic ligament changes (e.g. partial or complete rupture) Dynamic CT of the wrist will be performed before and after arthrography.

Device: Dynamic CTProcedure: Arthrography

Interventions

Dynamic CTDEVICE

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).

Normal subjectsWrist instability
ArthrographyPROCEDURE

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

Normal subjectsWrist instability

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CentralHNF

Nancy, Lorraine, 54000, France

Location

Related Publications (5)

  • 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.

    PMID: 25656096BACKGROUND

  • 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.

    PMID: 23571486BACKGROUND

  • 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.

    PMID: 22137722BACKGROUND

  • 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.

    PMID: 23863544BACKGROUND

  • 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.

    PMID: 37698480DERIVED

MeSH Terms

Conditions

Joint InstabilityWrist Injuries

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesArm InjuriesWounds and Injuries

Study Officials

  • Alain Blum, MD, PhD

    Central Hospital, Nancy, France

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 30, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2021

Study Completion

May 1, 2021

Last Updated

June 17, 2025

Record last verified: 2020-07

Locations

FR(1)