Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06067074
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-04
First Post:
2022-05-12
Brief Title:
Cost-effectiveness Volar Locking Plate or Non-operative Treatment Distal Radius Fracture
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Is it Cost-effective With Volar Plating Surgery Compared to Non-operative Treatment for Distal Radius Fracture in the Elderly
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HE-VOCAL
Brief 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 population140 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 WelfareThe life expectancy adjusted life years QALYs is calculated from prospectively collected results from EQ-5D
Patient population140 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 WelfareThe life expectancy adjusted life years QALYs is calculated from prospectively collected results from EQ-5D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None