Table 1 Frequency and scope of study visits
Visit | Visit 1 (Screening) | Visit 2 (Day of surgery) | Visit 3 (1 month post OP) | Visit 4 (6 months post OP) | Visit 5 (12 months post OP) | Visit 6 (18 months post OP) | Visit 7 (24 months post OP) |
|---|---|---|---|---|---|---|---|
Demographics and baseline clinical data | X | ||||||
Inclusion/exclusion criteria | X | ||||||
Randomization | X | ||||||
Clinical examination | X | X | X | X | |||
Ultrasound | X | X | |||||
Pain level (SPS, PDI) | X | X | X | X | X | ||
Quality of life (SF-36) | X | X | X | X | X | ||
Mental health (HADS-D) | X | X | |||||
Patient satisfaction (Likert scale) | X | X | X | X | X | ||
Surgical intervention | X | ||||||
Postoperative complications | X | X | X | ||||
AEs/SAEs | X | X | X | X | X | X | |
Costs of treatment | X | X | X | X | X | X |