Table 1.
Visit schedule
|
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 |
*Computed tomography (CT) and X-ray assessments are performed as a clinical routine according to the standards of care. They will be not performed for the purposes of the study. **Surgical procedures are performed according to the standard of care. No surgical interventions will be performed for the purposes of the study. ***CBVF, CERAMENT™|BONE VOID FILLER. ****Continuous documentation by patient, when applicable. §These examinations should also be performed at the trial end visit in case the patient prematurely drops out of the trial.