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 | • | ||||||||