Skip to main content

Table 1 Flowchart Sleutel-TRIAL

From: Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial

Date

Visit

1

Emergency

Room (ER)

2

Phone call

48 hours

after

ER visit

3 †

First

visit (pre-

operative

care)

4 †

Operation

5

2 weeks

6

6 weeks

7

3 months

8

1 year

9

2 years

Eligible? (checking in- and exclusion

        

criteria)

         

Patient information

        

Obtaining Informed Consent

 

2

 

2

    

Randomisation (operative vs. non-

 

1

       

operative treatment)

         

Case Record Form + Randomisation form

  

      

Preparing patient for operation

  

      

(aneasthesia i.e.) †

         

Peroperative Form †

   

     

X-rays

3

  

4

3

 

Follow-up Forms

    

5

5

5

5

 

DASH-score

    

 

SF-36 score (Quality of Life)

    

 

Constant score (+MicroFET2)

     

 

Telephone interview and written survey

        

  1. • 1: obtaining Informed Consent (verbally) for randomisation and planning of clinic visit
  2. • 2: obtaining definitive written Informed Consent
  3. • 3: X-rays: AP-view and 30 degrees cephalad view
  4. • 4: Panorama view
  5. • 5: Forms for the corresponding visit
  6. †: only for participants allocated to operative treatment