Screening and Follow-Up Clinical and Radiographic Exams | ||||||
---|---|---|---|---|---|---|
Action | Pre-operative | Intra-operative | Follow-Up Visit (biweekly 2-14 weeks) | Follow-Up Visit Until Union (biweekly) (>14Â weeks, determined by physician) | 6Â month follow-up visit | 1Â year Follow-Up visit |
Information letter | X | Â | Â | Â | Â | Â |
Obtain written informed consent | X | Â | Â | Â | Â | Â |
Complete eligibility checklist | X | Â | Â | Â | Â | Â |
Complete medical history and baseline characteristics (form) | X | Â | Â | Â | Â | Â |
Complete physical examination (form) | X | Â | X | X | X | X |
Surgery | Â | X | Â | Â | Â | Â |
- Operative form (surgical information) | Â | X | Â | Â | Â | Â |
- cB + cBMA preparation and administration |  | X |  |  |  |  |
- Bone biopsy fracture site | Â | X | Â | Â | Â | Â |
Lab assessments | X | Â | Â | Â | Â | Â |
Questionnaires | X | Â | X | Â | X | X |
Radiographic assessment | X | X | X | X | X | X |
Complication (form) | X | X | X | X | X | X |
Adverse events, withdrawals & re-operation (form) | X | X | X | X | X | X |