Humerusshaft Fractures Clinical Trial
Official title:
Comparison (Conservative Versus Operative) of Standardized Treatment for Defined Humerusshaft Fractures
Verified date | August 2020 |
Source | AO Innovation Translation Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to radiologically compare the fracture healing as well
as the functional treatment outcome of conservative and operative treatment of
defined humerusshaft fractures after 6w./12w./and 12 month based on the
modified "constant score".
Status | Completed |
Enrollment | 300 |
Est. completion date | October 2004 |
Est. primary completion date | October 2004 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - over age 16 - fracture according to AO classifications 12A2, 12A3, 12B2 - have to be available for the FU's Exclusion Criteria: - open fractures - polytraumatized patients - multiple sclerosis, paraplegic, or other conditions having a direct impact on the healing - pseudoarthrosis - pathological and refractures |
Country | Name | City | State |
---|---|---|---|
Switzerland | Spital Uster | Uster |
Lead Sponsor | Collaborator |
---|---|
AO Clinical Investigation and Publishing Documentation | AOAA Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | - Radiological comparison of fracture healing between the conservative versus operative treatment | Radiological comparison of fracture healing between the conservative versus operative treatment | 3 months to 12 months post OP | |
Primary | - Comparison of functional outcome | Comparison of functional outcome | 3 months to 12 months post OP | |
Secondary | - Collection of possible complication of the treatment | Collection of possible complication of the treatment | 3 months to 12 months post OP | |
Secondary | - Subject satisfaction | Subject satisfaction | 3 months to 12 months post OP | |
Secondary | - Financial impact of the compared treatments | Financial impact of the compared treatments | 3 months to 12 months post OP |