The Treatment of Clavicular Fractures
- Conditions
- Displaced, Midshaft Clavicular Fractures
- Interventions
- Procedure: osteosynthesisOther: sling
- Registration Number
- NCT00642265
- Lead Sponsor
- University Hospital, Ghent
- Brief Summary
Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.
Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
-
18 to 65 year
-
100% displaced midshaft clavicular fracture
-
shortening
- male: 18mm
- female: 14mm
- pregnancy
- pathological fracture
- open fracture
- history of frozen shoulder
- ipsilateral fracture of shoulder or scapula
- neurovascular injury
- contraindication to anaesthesia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 osteosynthesis operative treatment 2 sling conservative treatment
- Primary Outcome Measures
Name Time Method Union 1 year Functionality 1 year
- Secondary Outcome Measures
Name Time Method Time to heal 1 year Relation with smoking 1 year Complications 1 year Relation with medication 1 year Relation with job 1 year Cost 1 year
Trial Locations
- Locations (6)
Jan Palfijnziekenhuis
🇧🇪Ghent, Belgium
Stedelijk Ziekenhuis Roeselare
🇧🇪Roeselare, Belgium
Sint-Andries Ziekenhuis
🇧🇪Tielt, Belgium
AZ Sint Jan-Brugge
🇧🇪Brugge, Belgium
University Hospital Ghent
🇧🇪Ghent, Belgium
Stedelijk Ziekenhuis Aalst
🇧🇪Aalst, Belgium