Shoulder arthroplasty Shoulder prosthesis Total shoulder Totale schouder Schouder arthroplastiek Schouder prothese
Conditions
Interventions
T0: clinician-based CM score, patient-based CM score, Oxford Shoulder Score (OSS), Simple Shoulder Test (SST), Numeric Rating Scale (NRS), EuroQoL-5D (EQ-5D)
T1: clinician-based CM score, patient-bas
Sponsors
Department of Orthopaedic Surgery, Reinier de Graaf Hospital, Delft, the Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 years or older Scheduled to undergo shoulder arthroplasty Able to speak and write Dutch Willing to participate Able to provide written informed consent
Exclusion criteria
Exclusion criteria: Cognitive impairment Difficulty with the Dutch language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are: •Validity of both CM scores oConstruct validity of both CM scores •Reproducibility of both CM scores oExact agreement on ordinal item scores of both CM scores between T0 and T1 oSEM for continuous item scores and total composite score of both CM scores between T0 and T1 oExact and adjacent agreement between both CM ordinal item scores at T0 and T2 oSEM for continuous item scores and total composite score between both CM scores at T0 and T2 •IRT analysis oDiscrimination a and threshold b parameters of each item (+ ICC) and answer category (+ CRC) in both CM scores at T0 and T2 oIIF for each item in both CM scores oSIF for both CM scores | — |
Secondary
| Measure | Time frame |
|---|---|
| •Smallest Detectable Change (SDC) for the continuous item scores and total composite score of both CM scores between T0 and T1 •SDC for the continuous item scores and total composite score between both CM scores at T0 and T2 •Minimal Clinically Important Difference (MCID) of both CM scores | — |
Contacts
Public ContactBrechtje Hesseling
Reinier Haga Orthopedisch Centrum
Outcome results
None listed