Diagnosing Dynamic Scapholunate Instability with Computer Tomography (stressct)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Scapholunate Dissociation
• Intervention / Treatment: Diagnostic test: CT scan

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

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: chul ki goorens, medical doctor; Phone Number: 0032478907124; Email: cgoorens@msn.com
• Study Contact Backup: Name: Griet Vandervelpen, medical doctor; Phone Number: 003216809797; Email: griet.vandervelpen@rztienen.be

Study Locations

• Belgium
  • Boutersem, Belgium, 3370
    • Regionaal Ziekenhuis Tienen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• >18 years

Exclusion Criteria:

• Associated fractures or other lesions

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with scapholunate instability; to assess the dynamic character of the scapholunate joint in patients with scapholunate instability	Diagnostic test: CT scan; CT will be performed when the wrist is under loading compared to normal conditions. scapholunate kinematics will be examines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dorsal radioscaphoid translation	the translation of the scaphoid due to the instability is measured	preop assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scapholunate distance	scapholunate distance	preop assessment
scapholunate angle	scapholunate angle in sagital view	preop assessment

Collaborators and Investigators

• Sponsor: Regionaal Ziekenhuis Heilig Hart Tienen
• Investigators: Study Chair: Thierry Scheerlinck, clinical professor, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 16, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 16, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: CT; instability; dynamic; scapholunate
• Additional Relevant MeSH Terms: Mental Disorders; Dissociative Disorders
• Other Study ID Numbers: RZ T EC 109; EC 109 (Other Identifier: RZ Tienen)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No