Diagnostic performance of dynamic four-dimensional computed tomography (4D CT) for analyzing wrist ligament injuries - a reproducibility study of the image acquisition protocol.

Diagnostic performance of dynamic four-dimensional computed tomography (4D CT) for analyzing wrist ligament injuries - a reproducibility study of the image acquisition protocol. - 4D CT ligament wrist injuries imaging acquisition procedure

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56913

Enrollment

Registered

2024-08-01

Start date

2025-02-06

Completion date

Unknown

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

wrist instability

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Informed consent from the patient. • Suspicion of ligament wrist injury.

Exclusion criteria

Exclusion criteria: • <18 years  • medical history of wrist fracture, and/or wrist surgery • pregnancy

Design outcomes

Primary

Measure	Time frame
Main endpoint of the study: evaluate the test-retest reliability of 4DCT dynamic scanning of the radius, ulna and carpal bones. Motion analysis will be performed using the following 4D CT parameters: the scapholunate distance (SLD), lunatecapitate angle (LCA), radiolunate angle (RLA), radioscaphoid angle (RSA), scapholunate angle (SLA), radioulnar angle, sigmoid notch to ulnar head joint distance, radioulnar ratio, and radioulnar line distance. The kinematic values of normal wrists will be used as reference for analyzing the unstable wrists. A multivariate linear regression analysis will be performed to analyse the effect of demographic variables (age and sex) on the 4D CT parameters measured. Besides, , the test-retest reliability will be calculated with the CMC and the intraclass correlation coefficient (IC). This is used to evaluate the similarity between the two motion patterns. The total waveform reliability present between test and retest will be evaluated using the RMSD. When the two motion patterns are similar, the CMC tends towards 1, whereas in dissimilar waveforms, it tends towards 0.	—

Measure

Time frame

Main endpoint of the study: evaluate the test-retest reliability of 4DCT dynamic scanning of the radius, ulna and carpal bones. Motion analysis will be performed using the following 4D CT parameters: the scapholunate distance (SLD), lunatecapitate angle (LCA), radiolunate angle (RLA), radioscaphoid angle (RSA), scapholunate angle (SLA), radioulnar angle, sigmoid notch to ulnar head joint distance, radioulnar ratio, and radioulnar line distance. The kinematic values of normal wrists will be used as reference for analyzing the unstable wrists. A multivariate linear regression analysis will be performed to analyse the effect of demographic variables (age and sex) on the 4D CT parameters measured. Besides, , the test-retest reliability will be calculated with the CMC and the intraclass correlation coefficient (IC). This is used to evaluate the similarity between the two motion patterns. The total waveform reliability present between test and retest will be evaluated using the RMSD. When the two motion patterns are similar, the CMC tends towards 1, whereas in dissimilar waveforms, it tends towards 0.

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Secondary

Measure	Time frame
x	—

Countries

Netherlands

Outcome results