Table 1

Schedule of assessments

VisitScreen/introduction to studyFollow-up call(s)ScanPreoperative 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 3Week 26 follow-up visit 4Week 52 follow-up visit 5
Visit timingApproximately−12 weeksApproximately−6 weeks−4 weeks−4 weeksDay 02 weeks6 weeks12 weeks26 weeks52 weeks
Visit window±2 weeks±2 weeks±2 weeks±2 weeks±4 weeks±4 weeks±4 weeks
CRF required1 and 235, 6, 7, 8, 9 and 201011 and 2012 and 201314, 9 and 2015,6,7,8, 9 and 2016,6,7,8, 9 and 20
Patient ID and screening (inclusion/exclusion criteria)T 
Give study informationT 
Patient decisionT 
Scan bookedT 
Surgery slot bookedR 
Informed consentT (or at scan)T (if not given at screening) 
Letter to GPT 
MRI (or CT) scanR/T 
Full tibia X-rayR/T (any time preoperative)**T (anytime within 6 months of surgery)
Physical examination RRRRRR
ROM (plantar/dorsiflexion) TT
Randomisation T
Patient notified of randomisation T
Order kit R
Surgery R
Concomitant medication T (update log as required)
Record adverse eventsT (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.