wrist instability
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: for the pilot (healthy volunteers): age 20-40 year, signed informed consent for diagnotic clinical study: chronic wrist pain, unilateraal, suspect for Sl lesion
Exclusion criteria
Exclusion criteria: pilot study: 40 year, medical history of trauma, pain and surgery, stiff wrists, arthritis on X ray of 3D CT scan, pregnancy diagnostic clinical study: medical history of wrist fracture, know ligament lesion other dan SL, wrist surgery, inability to undergo an arthroscopy, wrist arthritis on X ray or 3D CT or pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main endpoint of the pilot study: investigate the visibility of the carpal bones and their movements (translations and rotations) relative to each other and to the radius on dynamic 4D CT scanning of the wrist. 4D CT parameters to be measured will be: the scapholunate distance (SLD), lunatecapitate angle (LCA), radiolunate angle (RLA), radioscaphoid angle (RSA) and scapholunate angle (SLA). Main endpoint for the clinical study: determine the diagnostic performance (sensitivity and specificity) of the 4D CT scan in the diagnosis of SLI in comparison with arthroscopic findings (gold standard). For this purpose, values of 4D CT parameters of SLI wrists (arthroscopy proven SLIL lesion), of non-SLI wrists (arthroscopy proven no SLIL lesion although clinically suspect) and of the asymptomatic wrists will be compared within and between patients.. We expect to get annotated values of 4D images and after analyzing to get the following results: 1) Range of values of 4D CT parameters (RLA, LCA, SLA, RSA, SLD) of instable wrists during wrist motions; proven on arthroscopy (group 1). 2) Range of values of 4D CT parameters (RLA, LCA, SLA, RAS, SLD) of SLI wrists during wrist motions; not proven on arthroscopy (group 2). 3) Range of values of 4D CT parameters (RLA, LCA, SLA, RSA, SLD) of asymptomatic (contralateral) wrists during wrist motions (group 3). The diagnostic performance (sensitivity and specificity) of the different 4D CT parameters used for the diagnosis of SLI in wrists suspected of SLI can thus be compared to plain radiographs and compared to measurements on standard 3D CT (group 1 vs. group 2). Furthermore, within each patient, the differences between SLI wrists and contralateral, asymptomatic wrists can be assessed (group 1 vs. group 3) as can the differences between non-proven SLI symptomatic wrists, and asymptomatic wrists (group 2 vs. 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pilot study: investigate the lowest dose possible to have an accurate measurement of movements of the carpal bones in a dynamic 4D CT scan in order to perform studies patients. 2. Clinical study: assess the association between 4D CT parameters and arthroscopic grades of SLIL (the Geissler classification). 3. Clinical study: determine the diagnostic performance (sensitivity and specificity) of the different 4D CT parameters used for the diagnosis of SLI, in wrists suspected of SLI in comparison to plain radiographs and standard 3D CT | — |
Countries
Netherlands
Outcome results
None listed