Procedures | Baseline (within 72 h prior to procedure) | Day of surgery | Postoperative stay in hospital | 3 Months after surgery ± 2 weeks | 6 Months after surgery ± 2 weeks | 12 Months after surgery ± 2 weeks |
---|---|---|---|---|---|---|
Inclusion/exclusion | X | X | ||||
Randomisation | X | |||||
Informed consent | X | |||||
Demographics | X | |||||
Medical history | X | |||||
Concomitant medications including use of analgesics or peripheral nerve block | X | X | Xd | X | X | X |
Physical examination (ROM) | X | Xd | X | X | X | |
Laboratory tests (virologya, CBCb, clinical chemistryc) | Xa–c | Xe,b,c | ||||
Coagulation parameters (INR, PTT) | X | |||||
Treatment application | X | |||||
Intraoperative data assessment | X | |||||
Clinical outcome score assessment (KSS/KOOS) | X | Xf | X | X | X | |
Surgical site assessment | Xd | X | X | X | ||
Wound healing assessment | Xd | |||||
Assessment of patient’s mobility on crutches (stairs) | Xd | |||||
Adverse events | X | Xd | X | X | X | |
Assessment of physiotherapy treatments after rehabilitation | X | X | X | |||
Calculation of overall costs of TKR | X |