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Table 1 Visit schedule

From: CERAMENT treatment of fracture defects (CERTiFy): protocol for a prospective, multicenter, randomized study investigating the use of CERAMENT™ BONE VOID FILLER in tibial plateau fractures

Visit no

1

2

3

4

5

6

7§

 

Day −7 – 0

Day 0

Day 1

Day 7

Week 6

Week 12

Week 26

Visit window

Screening

Day of surgery

± 1 day

± 3 days

± 1 weeks

± 2 weeks

± 3 weeks

Informed consent

X

      

Inclusion/Exclusion criteria

X

      

Demography

X

      

Patient employment status

X

      

Medical history

X

      

Weight and Height

X

      

Physical examination

X

      

Vital signs (pulse, blood pressure)

X

      

Pregnancy test (women of childbearing potential)

X

      

Concomitant medication/therapy

X

X

X

X

X

X

X

Evaluation of CT scan*

X

      

Evaluation of X-ray findings*

X

 

X

X

X

X

X

Randomization

X

      

Surgery** (autologous bone graft or treatment with CBVF***)

 

X

     

Procedure information (type and amount of bone graft, hardware used, etc. - time of surgery)

 

X

     

Adverse events

X

X

X

X

X

X

X

Device complaints

 

X

X

X

X

X

X

Clinical examination (pain, tenderness, warmth and swelling)

   

X

X

X

X

Documentation of treatments performed outside the trial center****

       

Pain medication

X

X

X

X

X

X

X

SF-12v2TM

X

  

X

X

X

X

Pain (VAS)

X

 

X

X

X

X

X

End of the trial

      

X

  1. *Computed tomography (CT) and X-ray assessments are performed as a clinical routine according to the standards of care. They will be not performed for the purposes of the study. **Surgical procedures are performed according to the standard of care. No surgical interventions will be performed for the purposes of the study. ***CBVF, CERAMENT™|BONE VOID FILLER. ****Continuous documentation by patient, when applicable. §These examinations should also be performed at the trial end visit in case the patient prematurely drops out of the trial.