wrist instability, SL ligament
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Radboud Universitair Medisch Centrum