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Dynamic CT vs arthroscopy in diagnosis of scapholunate ligament injuries

The role of dynamic CT compared to arthroscopy in the diagnosis of scapholunate ligament injuries: a multicenter study of feasibility, diagnostic accuracy, and cost-effectiveness - Dynamic CT vs arthroscopy for SL ligament diagnosis: a multicenter study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57930
Enrollment
100
Registered
2025-02-17
Start date
2026-02-17
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, SL ligament

Interventions

Patients will be recruited following referral from a secondary care physician and consented to have an additional diagnostic test, namely a 4D CT scan and questionnaires, concerning wrist function. A
bilateral 4D CT scan of the SLI wrist will be performed.&nbsp
Within two to three weeks of recruitment, the 4D CT scans will be acquired. To investigate patient reported outcomes, four questionnaires will send to the patient after the 4D CT scan via email. All t
Within two to three weeks after CT scanning, the patients will undergo arthroscopy of the symptomatic wrist (normal diagnostic procedure). After this arthroscopy the patient will receive one questionn
Three months after the inclusion the patient will receive three questionnaires by mail.&nbsp
Twelve months after treatment three questionnaires will be filled in by both surgically and non-surgically treated patients. Moreover, the patients who received surgery will undergo another 4D CT scan

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

Inclusion criteria: Between 16 – 60 years Suspicion of SLIL injuryClinical indication for arthroscopy Clear understanding of the Dutch language Range of motion (ROM) radial/ulnar deviation = 30 degrees left and right wristROM flexion = 25 degrees, extension =  30 degrees left and right wrist

Exclusion criteria

Exclusion criteria: Radial- or midcarpal arthritis visible on plain radiographNot able to undergo an arthroscopy Medical history of wrist trauma and/or wrist surgery that could affect wrist kinematics  Bilateral wrist complaints Inflammatory arthritis (rheumatoid) Pregnancy

Design outcomes

Primary

MeasureTime frame
The primary endpoint of this study is the diagnostic performance of 4D CT in detecting SL injuries, using arthroscopy as the reference standard. This includes the following diagnostic accuracy measures:Sensitivity (continuous)Specificity (continuous)Accuracy (continuous)Area under the ROC curve (AUC) (continuous)These metrics will be calculated by comparing the classification of SL ligament status (intact, partial lesion, complete lesion) as determined by two radiologists (4D CT) and three hand surgeons (arthroscopy), as described in Section 6.3. Each lesion type will be analyzed in a binary fashion (e.g., complete lesion vs. all others) to allow valid estimation of diagnostic metrics.

Secondary

MeasureTime frame
Secondary endpoints include:Observer agreement in the interpretation of arthroscopy videos:Intra-observer agreement (Cohen’s kappa)Inter-observer agreement (Fleiss’ kappa)Patient-reported outcomes (e.g., pain, function) and kinematic parameters at 12 months, in relation to:The treatment decision made through shared decision-makingThe findings of 4D CT and arthroscopyThese outcomes may include continuous variables (e.g., range of motion, PROM scores) and will be analyzed accordingly.

Countries

Netherlands

Contacts

Public ContactHS Vries

Radboud Universitair Medisch Centrum

hanne.vries@radboudumc.nl000000000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 14, 2026