NCT02336035

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Distal Radius Fracture

Interventions

Type	Name	Description
PROCEDURE	Volar plate	Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-09-01
• Completion: 2022-09-01
• First posted: 2015-01-12
• Last updated: 2021-09-10

Locations

1 site across 1 country: Norway