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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Volar Locking Plate
* Procedure: Plaster Cast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallell study arms with the intervention volar locking plate and control treatment forearm cast. We investigate the difference in health cost between the two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volar Locking Plate<br>Surgery with a Volar Locking Plate due to displaced distal radius fracture | Procedure: Volar Locking Plate<br>* Surgery<br>|
| Experimental: Non-operative treatment group<br>Patients allocated to non-operative treatment received a plaster cast for 4-5 weeks. | Procedure: Plaster Cast<br>* Non-operative treatment with a plaster cast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Cost-Effectiveness Ratio (ICER) at 1 year. | difference in cost divided by difference in quality of life | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute cost difference | difference in cost between treatments | 1 and 3 years | 
| ICER at 3 years | difference in cost divided by difference in quality of life | 3 years |