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Table 3 Flowchart

From: The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication

Obtained patients' information V1 V2 V3 V4 V5 V6a V7 V8 V9 V10
In-patient   x         
Out-patient x     x x x x x x
Demography & diagnosis x          
Basic physical examination x          
Neurological examination x     x   x x x x
Provide study information x          
Obtain informed consent x          
X-ray   x       x   
Randomisation   x         
ZCQ x   x x x x x x x x
MRDQ x   x   x x x x x x
Shuttle Walking Test x     x x x x x x
SF-36 x    x x x x x x x
McGill Pain Questionnaire x     x x x x x x
VAS for legs and back x   x x x x x x x x
Perceived Recovery      x x x x x x
Patient Global Impression of change      x x x x x x
EuroQol & VAS Quality of Life x   x x x x x x x x
Patient diary      x x x x x x
Review MRI x          
Complications   x x x x   x x x x
Re-operation      x x x x x x
  1. A, questionnaires will be sent per mail with request to complete and return them; V1, Visit 1 - Intake; V2; Visit 2 - surgery; V3, Visit 3 - Follow-up 2 weeks; V4, Visit 4 - Follow-up 4 weeks, V5, Visit 5 - Follow-up 8 weeks; V6, Visit 6 - Follow-up 3 months; V7, Visit 7: Follow-up 6 months; V8, Visit 8 - Follow-up 12 months; V9, Visit 9 - Follow-up 24 months; V10, Visit 10 - Follow-up 60 months