The Treatment of Clavicular Fractures

Displaced, Midshaft Clavicular Fractures Clinical Trial

Official title:

The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642265
• Other study ID #: 2007/573
• Status: Completed
• Phase: N/A
• Start date: April 2008
• Est. completion date: May 27, 2009

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 27, 2009
• Est. primary completion date: May 27, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Displaced, Midshaft Clavicular Fractures
• Fractures, Bone

Intervention

Procedure:
• osteosynthesis
operative treatment

Other:
• sling
conservative treatment

Locations

Country	Name	City	State
Belgium	Stedelijk Ziekenhuis Aalst	Aalst
Belgium	AZ Sint Jan-Brugge	Brugge
Belgium	Jan Palfijnziekenhuis	Ghent
Belgium	University Hospital Ghent	Ghent
Belgium	Stedelijk Ziekenhuis Roeselare	Roeselare
Belgium	Sint-Andries Ziekenhuis	Tielt

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Union		1 year
Primary	Functionality		1 year
Secondary	Complications		1 year
Secondary	Time to heal		1 year
Secondary	Cost		1 year
Secondary	Relation with medication		1 year
Secondary	Relation with smoking		1 year
Secondary	Relation with job		1 year

External Links

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