PROTEKT Trial
The sample size is designed to provide 80% power at 5% alpha to detect an effect size of 0.61 on FJS-12, accounting for an estimated 20% dropout. Patient satisfaction was reclassified from a primary to a secondary outcome after trial initi…
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The sample size is designed to provide 80% power at 5% alpha to detect an effect size of 0.61 on FJS-12, accounting for an estimated 20% dropout. Patient satisfaction was reclassified from a primary to a secondary outcome after trial initiation because it is closely related to and captured by FJS-12. The trial randomises 110 patients 1:1 to prehabilitation plus standard care or standard care alone, stratified by age using a cutoff of 67 years. Objective functional outcomes are assessed by physiotherapists blinded to group allocation to reduce detection bias. Analysis will follow both intention-to-treat and per-protocol principles, with missing data handled using sensitivity analyses. PROTEKT is a multicentre, parallel-group RCT conducted in two specialised orthopaedic outpatient rehabilitation units in the southeast healthcare region of Sweden.