Table 1 Timeline of the study – outcomes and variables assessed during the trial period
Timepoint | Study period | ||||||||
|---|---|---|---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Follow-up | ||||||
-4w | -1w | 0w | 2w | 10w | na | 24w | 48w | 96w | |
Enrolment: | |||||||||
Eligibility screening | X | ||||||||
Informed consent | X | ||||||||
Genicular nerve block | X | ||||||||
Allocation | X | ||||||||
Interventions: | |||||||||
Cryoeurolysis (CRYO) | X | ||||||||
Sham treatment (SHAM) | X | ||||||||
GLA:D (SHAM & CRYO) | X | X | |||||||
Assessments: | |||||||||
Pain | X | X | X | X | X | X | |||
Functional performance | X | X | X | X | X | X | |||
KOOS | X | X | X | X | X | X | |||
EQ5D | X | X | X | X | X | X | |||
Adverse effects | X | X | X | X | X | X | |||
Analgesics | X | X | X | X | X | X | |||