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

Table 3 Flowchart

Obtained patients' information	V1	V2	V3	V4	V5	V6^a	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

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

ISSN: 1471-2474