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

Not Applicable

Active, not recruiting

• Conditions: Aged; Quality of Life; Cost-Benefit Analysis; Wrist Fracture; Postoperative Complications; Radius Fractures; Wrist Injuries; Health Care Utilization
• Interventions: Procedure: Plaster Cast; Procedure: Volar Locking Plate

• Registration Number: NCT06067074
• Lead Sponsor: Karolinska Institutet

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 Timeline

• Study Start: 2022-02-08
• Study First Submitted: 2022-05-12
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-02
• Last Update Submitted: 2023-10-02
• Study First Posted: 2023-10-04
• Last Update Posted: 2023-10-04
• Primary Completion: 2024-11-04
• Study Completion: 2024-11-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-operative treatment group	Plaster Cast	Patients allocated to non-operative treatment received a plaster cast for 4-5 weeks.
Volar Locking Plate	Volar Locking Plate	Surgery with a Volar Locking Plate due to displaced distal radius fracture

Primary Outcome Measures

Name	Time	Method
Incremental Cost-Effectiveness Ratio (ICER) at 1 year.	1 year	difference in cost divided by difference in quality of life

Secondary Outcome Measures

Name	Time	Method
Absolute cost difference	1 and 3 years	difference in cost between treatments
ICER at 3 years	3 years	difference in cost divided by difference in quality of life

Trial Locations

Locations (1)

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division ot Ortopeadics; 🇸🇪 Stockholm, Sweden