Study period | |||||||
---|---|---|---|---|---|---|---|
Enrolment/baseline | Intervention | Post-allocation | Close-out | ||||
Timepoint** | − 2 weeks | 0 | Post-intervention | 1 month | 4 months | 8 months | 12 months |
Enrolment: | |||||||
Eligibility screen | X | ||||||
Informed consent | X | ||||||
Randomization | X | ||||||
Allocation | X | ||||||
Interventions: | |||||||
Genicular artery embolization | X | ||||||
Sham procedure | X | ||||||
Assessments: | |||||||
Blood examination | X | ||||||
Usage of co-interventions | X | X | X | X | X | ||
VAS pain | X | X | X | X | X | ||
KOOS questionnaire | X | X | X | X | X | ||
ICOAP questionnaire | X | X | X | X | X | ||
painDETECT questionnaire | X | X | X | X | X | ||
EQ-5D-5L questionnaire | X | X | X | X | X | ||
Global perceived effect questionnaire | X | ||||||
PPT measurement | X | X | X | X | X | ||
MRI examination | X | X | X | ||||
Adverse event assessment | X | X | X | X | X | ||
Concealment of allocation assessment | X |