Diagnosing Dynamic Scapholunate Instability with Computer Tomography

NCT ID: NCT06695260

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

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

Conditions

Scapholunate Dissociation

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients with scapholunate instability

to assess the dynamic character of the scapholunate joint in patients with scapholunate instability

Group Type: EXPERIMENTAL

CT scan

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

CT scan

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• >18 years

Exclusion Criteria

• Associated fractures or other lesions

• Neurological and severe psychological disorders
• History of ipsilateral wrist disorders
• Substance abuse

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Regionaal Ziekenhuis Heilig Hart Tienen

OTHER

Sponsor Role: lead

Responsible Party

Goorens Chul Ki

principal investigator, medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thierry Scheerlinck, clinical professor

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Locations

Regionaal Ziekenhuis Tienen

Boutersem, , Belgium

Countries

Belgium

Central Contacts

chul ki goorens, medical doctor

Role: CONTACT

cgoorens@msn.com

0032478907124

Griet Vandervelpen, medical doctor

Role: CONTACT

griet.vandervelpen@rztienen.be

003216809797

Other Identifiers

EC 109

Identifier Type: OTHER

Identifier Source: secondary_id

RZ T EC 109

Identifier Type: -

Identifier Source: org_study_id