Study schedule
Preoperatory medical examination (T0) | Surgical procedure | 24 hours post-op (T1) | 1-month follow-up (T2) | 3-month follow-up (T3) | 6-month follow-up (T4) | 12-month follow-up (T5) | |
Inclusion/exclusion criteria evaluation | X | X | |||||
Informed consent signing | X | ||||||
Demographic data | X | ||||||
Medical history | X | ||||||
Randomisation | X | ||||||
WOMAC | X | X | X | X | X | ||
IKDC subjective | X | X | X | X | X | ||
IKDC objective | X | X | X | X | X | ||
KOOS | X | X | X | X | X | ||
EQ-VAS | X | X | X | X | X | ||
Tegner | X | X | X | X | X | ||
Patient expectation on the treatment | X | ||||||
Patient judgement on the treatment | X | X | |||||
Adverse events reporting | X | X | X | X | X | X | |
Medication tracking sheet | X | X | X | X | |||
Biomechanical analysis | X | X | |||||
Radiography and KL evaluation | X | X | X | X | |||
3T MR and WORMS | X | X | |||||
Serum/plasma and urine collection | X | X | X | X | X | X | |
Synovial membrane and SF collection | X |
EQ-VAS, EuroQol-Visual Analogue Scale; IKDC, International Knee Documentation Committee; KL, Kellgren-Lawrence; KOOS, Knee Injury and Osteoarthritis Outcome Score; MR, magnetic resonance; SF, synovial fluid; T, Tesla; WOMAC, Western Ontario and McMaster Universities Arthritis Index; WORMS, Whole-Organ MRI Score.