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NCT Number: NCT06695260

Diagnosing Dynamic Scapholunate Instability with Computer Tomography

Scapholunate instability can result in debilitating pain, dysfunction, and secondary arthritis. If treatment is required, the instability should ideally be addressed in the dynamic stage, before non-reducible non-repairable deformation occurs. Early diagnosing of instability of the scapholunate joint can be a complex task.

In this study, the use of computer tomography (CT) scan is evaluatedto reveal the dynamic characteristics of the scapholunate instability. A CT-scan will be performed of the non-stressed wrist and a CT-scan under loading to potentially visualize increase of dorsal scaphoid translation, which is considered as primary cause of dorsoradial radioscaphoid pain in the early stage of scapholunate instability.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regionaal Ziekenhuis Tienen

Boutersem, 3370, Belgium

About this study

Part 1: Assessment of the normal scapholunate stability with CT scan with and without loading in patients without symptoms of scapholunate instability

40 patients without scapholunate instability, with normal scaphoid shift test will be included. Radiographs of both wrists will be performed (anteroposterior view in pronation, clenched fist in pronation, ulnar deviation + clenched fist in supination and a sagittal view). Measurements will be the scapholunate, radiolunate, capitolunate angle and the radioscaphoid distance/angle. Then, they will undergo CT scan of both wrists without loading of the wrists (full pronation). Then, a CT scan of both wrists with loading of the wrists (supination, ulnar deviation and clenched fist) will be performed. Segmentation of the CT scans will be performed to be able to compare both CT scans. The measurements will be scapholunate distance, radioscaphoid distance, radiolunate distance, radioscaphoid rotation, radiolunate rotation and scapholunate rotation.

Exclusion criteria

<18 years, arthritis, previous wrist disorders

Part 2: Assessment of the scapholunate instability with CT scan with and without loading in patients with symptoms of scapholunate instability

40 patients with scapholunate instability, with positive scaphoid shift test will be included. Radiographs of both wrists will be performed (anteroposterior view in pronation, clenched fist in pronation, ulnar deviation + clenched fist in supination and a sagittal view). Measurements will be the scapholunate, radiolunate, capitolunate angle and the radioscaphoid distance/angle. Then, they will undergo CT scan of both wrists without loading of the wrists (full pronation). Then, a CT scan of both wrists with loading of the wrists (supination, ulnar deviation and clenched fist) will be performed. Segmentation of the CT scans will be performed to be able to compare both CT scans. The measurements will be scapholunate distance, radioscaphoid distance, radiolunate distance, radioscaphoid rotation, radiolunate rotation and scapholunate rotation. MRI scan will be performed to reveal the ligament attenuation of the scapholunate complex.

Treatment options will be proposed as usual: conservative (medication, physiotherapy) and surgery (arthroscopic capsuloligamentous repair). If arthroscopy is agreed, arthroscopic assessment of the ligamentous complex will be performed.

Correlation of the CT findings will be performed with the MRI and arthroscopic findings.

Exclusion criteria

<18 years, arthritis, previous wrist disorders

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years

Exclusion criteria

  • Associated fractures or other lesions
  • Neurological and severe psychological disorders
  • History of ipsilateral wrist disorders
  • Substance abuse

Treatment and study plan

CT Scan

Diagnostic Test

CT will be performed when the wrist is under loading compared to normal conditions. scapholunate kinematics will be examines

Primary outcomes

  1. dorsal radioscaphoid translation

    Time frame: preop assessment

    the translation of the scaphoid due to the instability is measured

Secondary outcomes

  1. scapholunate distance

    Time frame: preop assessment

    scapholunate distance

  2. scapholunate angle

    Time frame: preop assessment

    scapholunate angle in sagital view

Study contacts

Contact information is provided by the study sponsor or research team.

Griet Vandervelpen, medical doctor

CONTACT

[email protected]

003216809797

chul ki goorens, medical doctor

CONTACT

[email protected]

0032478907124

Sponsors and collaborators

Lead sponsor

Regionaal Ziekenhuis Heilig Hart Tienen

Other

Registry information

Acronym: stressct

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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