Table 3 Participant timeline
Pre-inclusion visit (V0) D0 -9 to 120 days | Inclusion visit (V1) D0 -2 to 90 days | Surgery (V2) D0 | 3 months follow-up (V3) D0 + 90 days ± 30 | 12 months follow-up (V4) D0 + 360 days ± 30 | 24 months follow-up (V5) D0 + 720 days ± 30 | |
|---|---|---|---|---|---|---|
ENROLMENT: | ||||||
Patient information | X | |||||
Eligibility screening | X | |||||
Urinary pregnancy test | X | |||||
Informed consent | X | |||||
Allocation | X | |||||
INTERVENTION: | ||||||
Radiation exposure measurement | X | |||||
ASSESSMENT: | ||||||
CT scan | Xa | X | X | |||
Full-spine x-ray or EOS | X | X | X | X | ||
ODI score | X | X | X | X | ||
Pain on VAS | X | X | X | X | ||
HAD scale | X | X | X | X | ||
Sensory status | X | X | X | X | ||
Motor status (MRC) | X | X | X | X | ||
EQ5D-5L questionnaire | X | X | X | |||
Complications | X | X | X | X | ||
Concomitant treatment | X | X | X | X | X | |
Adverse events | X | X | X | X | ||