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

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

ISSN: 1471-2474