Clinical Trials Directory

Trials / Unknown

UnknownNCT06067074

Cost-effectiveness, Volar Locking Plate or Non-operative Treatment Distal Radius Fracture

Is it Cost-effective With Volar Plating Surgery Compared to Non-operative Treatment for Distal Radius Fracture in the Elderly?

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
140 (actual)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
70 Years
Healthy volunteers
Not accepted

Summary

A cost-utility analysis based on an earlier published RCT comparing surgery with volar locking plate to non-operative treatment for the elderly with a displaced distal radius fracture.

Detailed description

Study design: A cost-utility analysis of a patient population included in a previous published randomized controlled trial. Patient population:140 patients 70 years of age or older with a displaced distal radius fracture that met the inclusion and no exclusion criteria at Danderyd Hospital or Södersjukhuset Hospital were randomized to volar locking plate or non-operative treatment with a cast. Primary outcome: Incremental cost-effectiveness ratio (ICER) at 1 and 3 years. Data collection: Prospectively collected clinical data is available for 4, 12, weeks, 1 and 3 years. Costs will be analysed regarding surgical equipment, inpatient stay, surgical time. Prescriptions of analgesics and antibiotics as well as inpatient and outpatient consumption over a three years period after the injury will be retrieved from the Swedish National Board of Health and Welfare.The life expectancy adjusted life years (QALYs) is calculated from prospectively collected results from EQ-5D.

Conditions

Interventions

TypeNameDescription
PROCEDUREVolar Locking PlateSurgery
PROCEDUREPlaster CastNon-operative treatment with a plaster cast

Timeline

Start date
2022-02-08
Primary completion
2024-11-04
Completion
2024-11-04
First posted
2023-10-04
Last updated
2023-10-04

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT06067074. Inclusion in this directory is not an endorsement.