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