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

Karolinska Institutet140 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

140

Conditions

Radius Fractures Aged Cost-Benefit Analysis Wrist Fracture Quality of Life Wrist Injuries Postoperative Complications Health Care Utilization

Interventions

Volar Locking PlatePROCEDURE

Surgery

Plaster CastPROCEDURE

Non-operative treatment with a plaster cast

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria * patient \>70 years * wrist radiograph \>20° dorsal tilt and/or +/-4 mm axial shortening Exclusion Criteria * Former disability of either wrist * Intra-articular fractures with a step-off of \>1 mm or a gap of \> 1 mm (at Sodersjukhuset Hospital) * High-energy trauma (Sodersjukhuset Hospital) * Associated ulnar fracture * Injury to ipsilateral upper extremity * Rheumatoid arthritis or other severe joint disorders * Dementia or Pfeiffer score of \<5 at Sodersjukhuset Hospital and \<8 at Danderyd Hospital * Drug or alcohol abuse or psychiatric disorder * Dependency in activities of daily living * Patient not a resident within the catchment area of the 2 centers * Fracture diagnosed \>3 days from injury at Sodersjukhuset Hospital and \>6 days at Danderyd Hospital * Patient not fit for surgery or American Society of Anesthesiologists class 4

Locations (1)

Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division ot Ortopeadics

Stockholm, Sweden

Outcomes

Primary Outcomes

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

difference in cost divided by difference in quality of life

Time frame: 1 year

Secondary Outcomes

Absolute cost difference

difference in cost between treatments

Time frame: 1 and 3 years

ICER at 3 years

difference in cost divided by difference in quality of life

Time frame: 3 years

Data from ClinicalTrials.gov

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