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Clinical Trials/NCT06067074
NCT06067074
Active, not recruiting
Not Applicable

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

Karolinska Institutet1 site in 1 country140 target enrollmentStarted: February 8, 2022Last updated:
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ConditionsRadius FracturesAgedCost-Benefit AnalysisWrist FractureQuality of LifeWrist InjuriesPostoperative ComplicationsHealth Care Utilization

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
140
Locations
1
Primary Endpoint
Incremental Cost-Effectiveness Ratio (ICER) at 1 year.
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
70 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incremental Cost-Effectiveness Ratio (ICER) at 1 year.

Time Frame: 1 year

difference in cost divided by difference in quality of life

Secondary Outcomes

  • Absolute cost difference(1 and 3 years)
  • ICER at 3 years(3 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cecilia Mellstrand Navarro

associate professor

Karolinska Institutet

Study Sites (1)

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