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The Treatment of Clavicular Fractures

Not Applicable
Completed
Conditions
Displaced, Midshaft Clavicular Fractures
Interventions
Procedure: osteosynthesis
Other: 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
Inclusion Criteria
  • 18 to 65 year

  • 100% displaced midshaft clavicular fracture

  • shortening

    • male: 18mm
    • female: 14mm
Exclusion Criteria
  • 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
GroupInterventionDescription
1osteosynthesisoperative treatment
2slingconservative treatment
Primary Outcome Measures
NameTimeMethod
Union1 year
Functionality1 year
Secondary Outcome Measures
NameTimeMethod
Time to heal1 year
Relation with smoking1 year
Complications1 year
Relation with medication1 year
Relation with job1 year
Cost1 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

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