Visit no | 1 | 2 | 3 | 4 | 5 | 6 | 7§ |
---|---|---|---|---|---|---|---|
Day −7 – 0 | Day 0 | Day 1 | Day 7 | Week 6 | Week 12 | Week 26 | |
Visit window | Screening | Day of surgery | ± 1 day | ± 3 days | ± 1 weeks | ± 2 weeks | ± 3 weeks |
Informed consent | X | ||||||
Inclusion/Exclusion criteria | X | ||||||
Demography | X | ||||||
Patient employment status | X | ||||||
Medical history | X | ||||||
Weight and Height | X | ||||||
Physical examination | X | ||||||
Vital signs (pulse, blood pressure) | X | ||||||
Pregnancy test (women of childbearing potential) | X | ||||||
Concomitant medication/therapy | X | X | X | X | X | X | X |
Evaluation of CT scan* | X | ||||||
Evaluation of X-ray findings* | X | X | X | X | X | X | |
Randomization | X | ||||||
Surgery** (autologous bone graft or treatment with CBVF***) | X | ||||||
Procedure information (type and amount of bone graft, hardware used, etc. - time of surgery) | X | ||||||
Adverse events | X | X | X | X | X | X | X |
Device complaints | X | X | X | X | X | X | |
Clinical examination (pain, tenderness, warmth and swelling) | X | X | X | X | |||
Documentation of treatments performed outside the trial center**** | |||||||
Pain medication | X | X | X | X | X | X | X |
SF-12v2TM | X | X | X | X | X | ||
Pain (VAS) | X | X | X | X | X | X | |
End of the trial | X |