Table 2 Time table and follow-up schedule
RODEO-trial | Enrollment | Randomization / Allocation | Follow-up | ||
|---|---|---|---|---|---|
TIMEPOINT | Post-operatively | 8 – 12 weeks post-operatively | 3 months Post-operatively | 6 months Post-operatively | 12 months Post-operatively |
Enrollment | |||||
Eligibility screening | X | ||||
Informed Consent | X | ||||
Intervention | |||||
Removal of syndesmotic screw (according to randomization) | X | ||||
Assessment | |||||
Plain radiographs | X | X | |||
OMAS | X | X | X | ||
Visual analogue pain scale (VAS) | X | X | X | ||
Range-of-Motion | X | X | X | ||
POWI | X | ||||
AOFAS | X | X | X | ||
EQ-5D-5 L | X | X | X | ||
i-MCQ | X | X | X | ||
i-PCQ | X | X | X | ||