Schedule of assessments
| Visit | Screen/introduction to study | Follow-up call(s) | Scan | Preoperative assessment (baseline) | Randomisation (inform patient) | Surgery (week 0) | Week 2 follow-up visit 1: clinical review* | Week 6 follow-up visit 2* | Week 12 follow-up visit 3 | Week 26 follow-up visit 4 | Week 52 follow-up visit 5 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit timing | Approximately−12 weeks | Approximately−6 weeks | −4 weeks | −4 weeks | Day 0 | 2 weeks | 6 weeks | 12 weeks | 26 weeks | 52 weeks | |
| Visit window | ±2 weeks | ±2 weeks | ±2 weeks | ±2 weeks | ±4 weeks | ±4 weeks | ±4 weeks | ||||
| CRF required | 1 and 2 | 3 | 5, 6, 7, 8, 9 and 20 | 10 | 11 and 20 | 12 and 20 | 13 | 14, 9 and 20 | 15,6,7,8, 9 and 20 | 16,6,7,8, 9 and 20 | |
| Procedure | |||||||||||
| Patient ID and screening (inclusion/exclusion criteria) | T | ||||||||||
| Give study information | T | ||||||||||
| Patient decision | T | ||||||||||
| Scan booked | T | ||||||||||
| Surgery slot booked | R | ||||||||||
| Informed consent | T (or at scan) | T (if not given at screening) | |||||||||
| Letter to GP | T | ||||||||||
| MRI (or CT) scan | R/T | ||||||||||
| Full tibia X-ray | R/T (any time preoperative)** | T (anytime within 6 months of surgery) | |||||||||
| Physical examination | R | R | R | R | R | R | |||||
| EQ-5D | T | T | T | T | |||||||
| MOXFQ | T | T | T | ||||||||
| FAAM | T | T | T | ||||||||
| CSRI | T | T | T | T | |||||||
| ROM (plantar/dorsiflexion) | T | T | |||||||||
| Randomisation | T | ||||||||||
| Patient notified of randomisation | T | ||||||||||
| Order kit | R | ||||||||||
| Surgery | R | ||||||||||
| Concomitant medication | T (update log as required) | ||||||||||
| Record adverse events | T (record on AE log or report on notification of SAE from consent onwards) | ||||||||||
*In all cases, at the first post-op visit complete the Visit 1 Clinical Review. If this falls within the Visit 2 window report this as a Protocol Deviation. If Visit 2 is then missed report this as a second Protocol Deviation.
**Only request full tibia x-ray at Scan or Pre-Op visit if not already taken as part of routine care.
AE, adverse events; CRF, case report forms; CSRI, Client Service Receipt Inventory; EQ-5D, EuroQol five dimensions; FAAM, foot and ankle ability measure; GP, general practitioner; MOXFQ, Manchester Oxford Foot Questionnaire; R, routine procedure; trial related; ROM, range of movement; SAE, serious adverse events.