Is it Cost-effective With Volar Plating Surgery Compared to Non-operative Treatment for Distal Radius Fracture in the Elderly?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incremental Cost-Effectiveness Ratio (ICER) at 1 year.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient >70 years
- •wrist radiograph >20° dorsal tilt and/or +/-4 mm axial shortening
排除标准
- •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
研究组 & 干预措施
Volar Locking Plate
Surgery with a Volar Locking Plate due to displaced distal radius fracture
干预措施: Volar Locking Plate (Procedure)
Non-operative treatment group
Patients allocated to non-operative treatment received a plaster cast for 4-5 weeks.
干预措施: Plaster Cast (Procedure)
结局指标
主要结局
Incremental Cost-Effectiveness Ratio (ICER) at 1 year.
时间窗: 1 year
difference in cost divided by difference in quality of life
次要结局
- Absolute cost difference(1 and 3 years)
- ICER at 3 years(3 years)
研究者
Cecilia Mellstrand Navarro
associate professor
Karolinska Institutet