Table 1.
Screening | Baseline (Month 0) | Day 3 Post-Infusion | Month 3 | Month 6 | Month 12 | Day 3 Post-Infusion | Month 18 | Month 24 | |
---|---|---|---|---|---|---|---|---|---|
Informed consent | x | ||||||||
Clinical examination | x | ||||||||
Knee x-ray | x | ||||||||
Bloods | x | x* | |||||||
Knee MRI | x | x | x | ||||||
Randomisation | x | ||||||||
Clinic measures | |||||||||
Leg strength | x | x | x | x | |||||
Height and weight | x | x | x | ||||||
First void fasting urine | x* | x* | |||||||
Infusion | x | x | |||||||
Questionnaire measures | |||||||||
Demographics (sex, date of birth) | x | ||||||||
Knee VAS | x | x | x | x | x | x | x | ||
Knee WOMAC | x | x | x | x | x | x | |||
Medication use | x | x | x | x | x | x | |||
Knee surgery | x | x | x | x | x | x | |||
Knee joint injection | x | x | x | x | |||||
Safety (adverse events) | x | x | x | x | x | x | x | x | |
Acute phase reactions | x | x | |||||||
Hand VAS | x | x | x | x | x | x | |||
Back VAS | x | x | x | x | x | x | |||
AQoL-4D | x | x | x | ||||||
Overall change in pain and function | x | ||||||||
Treatment guessing | x |
*Only being performed at the Hobart, Melbourne and Sydney study sites
MRI magnetic resonance imaging, VAS visual analogue scale, WOMAC Western Ontario and McMasters Universities Osteoarthritis Index, AQoL-4D The Assessment of Quality of Life