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Distal Radius Fractures in Patients Over 65 Years, Operation or Cast? — DROC  

Distal Radius Fracture Clinical Trial

Official title:
Unstable Distal Radius Fractures in Patients Over 65 Years. Conservative Treatment With Cast Immobilization Versus Volar Locking Plate. A Prospective Randomized Controlled Trial.

Clinical Trial Summary

Eligible patients that sign an informed consent will be randomized to operation with volar locking plate or cast immobilization. Primary follow-up after 1 year.

Clinical Trial Description

The investigators want to investigate if there is a difference between operative treatment with volar locking plates and cast immobilization in patient above 65 years with unstable distal radius fractures AO/OTA type A and C . Eligible patients that meets the radiological criteria (see inclusion criteria) will be randomized to cast immobilization or operation with volar locking plate. The investigators are planning a non-inferiority design. The current study will test the following null hypothesis: In patients over 65 years of age with unstable distal radius fractures AO/OTA type A and C,volar locking plates are superior to cast immobilization by more than 8 points, as evaluated by quick-DASH at 12 months follow-up. The investigators will perform a cost-effectiveness analysis comparing QALYs (Quality-adjusted life years) and costs with the two interventions the first year of follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02336035
Study type Interventional
Source Oslo University Hospital
Contact
Status Active, not recruiting
Phase N/A
Start date January 2015
Completion date September 2022
View Details
See also
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