Radius Fractures, Aged, Cost-Benefit Analysis, Wrist Fracture, Quality of Life, Wrist Injuries, Postoperative Complications, Health Care Utilization
Conditions
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.
Interventions
PROCEDUREVolar Locking Plate
Surgery
PROCEDUREPlaster Cast
Non-operative treatment with a plaster cast
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incremental Cost-Effectiveness Ratio (ICER) at 1 year. | 1 year | difference in cost divided by difference in quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed