Status:
COMPLETED
Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures
Lead Sponsor:
Helsinki University Central Hospital
Conditions:
Clavicle
Fracture
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.
Detailed Description
Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. Old-established treatment practices, based on no randomised controlled t...
Eligibility Criteria
Inclusion
- a completely displaced middle third clavicle fracture, no cortical contact between main fragments
- fresh fracture, treatment within seven days after injury
- age between 18 and 70 years
- provided informed consent
Exclusion
- fracture was not dislocated
- multiple injured patient
- associated neurovascular injury, or suspicion of it
- reduced cooperation
- cancer or any severe illness impairing health
- pathological fracture
- treatment seven days after injury
- open fracture
- corticosteroid or immunosuppressive medication
- upper extremity fracture at same time
- an earlier clavicle or shoulder region fracture
- pregnancy
- lack of consent
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01199653
Start Date
August 1 2004
End Date
November 1 2009
Last Update
September 13 2010
Active Locations (1)
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1
Helsinki University Central Hospital, Töölö Hospital
Helsinki, Uusimaa, Finland, 00260