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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