Skip to main content

Table 1 Schedule of events

From: Determination of the efficacy of EVICEL™ on blood loss in orthopaedic surgery after total knee replacement: study protocol for a randomised controlled trial

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
  1. aVirology: Hep B/C and HIV screening
  2. bCBC: Hb, leucocytes
  3. cClinical chemistry: CRP
  4. dAssessment daily during the visits (except for Sundays as for the physical examination)
  5. eAssessment on days 2, 4 and 6 (+/− 1 day) and on day 7
  6. fAssessment on day 7