跳至主要内容
临床试验/NCT06067074
NCT06067074进行中(未招募)不适用

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

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年2月8日最近更新:
适应症

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

入选标准

  • 未提供

排除标准

  • 未提供

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cecilia Mellstrand Navarro

associate professor

Karolinska Institutet

研究点 (1)

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