Diagnosing Dynamic Scapholunate Instability with Computer Tomography

NCT06695260 | Not Yet Recruiting

• 2 other identifiers: RZ T EC 109EC 109
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Scapholunate Dissociation

Keywords

dynamic; scapholunate; instability; CT

Outcome Measures

Primary Outcomes (1)

• dorsal radioscaphoid translation

  the translation of the scaphoid due to the instability is measured

  preop assessment

Secondary Outcomes (2)

• scapholunate distance

  preop assessment

• scapholunate angle

  preop assessment

Study Arms (1)

patients with scapholunate instability

EXPERIMENTAL

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

Diagnostic Test: CT scan

Interventions

CT scan DIAGNOSTIC_TEST

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

patients with scapholunate instability

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years

You may not qualify if:

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

Sponsors & Collaborators

• Regionaal Ziekenhuis Heilig Hart Tienen: lead

Study Sites (1)

Regionaal Ziekenhuis Tienen

Boutersem, 3370, Belgium

Location

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Thierry Scheerlinck, clinical professor

  Universitair Ziekenhuis Brussel

  STUDY CHAIR

Central Study Contacts

chul ki goorens, medical doctor

CONTACT

0032478907124; cgoorens@msn.com

Griet Vandervelpen, medical doctor

CONTACT

003216809797; griet.vandervelpen@rztienen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, medical doctor

Model Details: Part 1: To assess the normal dynamics of the scapholunate joint in patients without scapholunate instability with CT when the wrist is under loading compared to normal conditions Part 2: To assess the dynamic character of the scapholunate joint in patients with scapholunate instability with CT when the wrist is under loading compared to normal conditions

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 19, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)