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The Treatment of Clavicular Fractures

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00642265
Enrollment
100
Registered
2008-03-25
Start date
2008-04-30
Completion date
2009-05-27
Last updated
2023-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Displaced, Midshaft Clavicular Fractures

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.

Interventions

PROCEDUREosteosynthesis

operative treatment

OTHERsling

conservative treatment

Sponsors

AZ Sint-Jan AV
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Union1 year
Functionality1 year

Secondary

MeasureTime frame
Cost1 year
Relation with medication1 year
Complications1 year
Relation with job1 year
Relation with smoking1 year
Time to heal1 year

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026