Displaced, Midshaft Clavicular Fractures Clinical Trial
Official title:
The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study
NCT number | NCT00642265 |
Other study ID # | 2007/573 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2008 |
Est. completion date | May 27, 2009 |
Verified date | January 2023 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent | AZ Sint-Jan AV |
Belgium,
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 |