displaced midshaft clavicular fractures clavicula locking plate fixation non-operative treatment
Conditions
Interventions
1. Non-operative treatment with a sling
2. Operative treament: Plate fixation.
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-60 years; 2. A completely displaced midshaft fracture (no fracture side contact of distal and proximal fragments) according to Robinson classification 2B1 and 2B2; 3. No medical contra indications to general anaesthesia; 4. Signed informed consent by the patient or a legal representative.
Exclusion criteria
Exclusion criteria: 1. Patient younger than 18 years or older than 60 years; 2. A fracture in the proximal or distal third of the clavicle; 3. A pathologic fracture (bony abnormalities at the side of the fracture); 4. An open fracture; 5. Neurovascular injury with objective neurological findings on physical examination; 6. An associated head injury (Glasgow Coma Scale <12); 7. An upper extremity fracture distal to the shoulder; 8. A fracture seen more than 14 days after injury;; 9. Inability to give informed consent with the randomisation procedure; 10. A medical contra-indication to surgery/ anaesthesia (such as a heart disease, kidney failure or active chemotherapy); 11. Inability to comply with follow-up; 12. Prior surgery to the shoulder; 13. Prior shoulder complaints.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete radiological consolidation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complete functional recovery of the shoulder to the level of mobility prior to fracture; 2. Complications; 3. Quality of life; 4. Cosmetic appearance. | — |
Contacts
Public ContactS.A. Stegeman
Albinusdreef 2
Outcome results
None listed