Minimal Invasive Volar Plating Versus Cast Immobilization for Treatment of Stable Non-displaced Distal Radial Fractures.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- QALY
研究概览
简要总结
Nondisplaced distal radial fractures are nowadays treated by plaster cast immobilization. In this study, the investigators challenge this classical standard treatment with a surgical solution: minimal invasive volar plating with pronatus quadratus sparing approach. Potential benefits of this surgical treatment are higher cost effectiveness, economical benefit, earlier recuperation of professional and recreational activities, earlier functional recuperation by faster clinical recovery (range of motion, grip strength) and decreased risk of secondary fracture displacement. Potential drawbacks are surgical risks and complications.
详细描述
Randomized controlled trial Number still to be determined by power analysis on economical outcome measurement Similar study number = 90 Randomization by computer.
RZ Tienen, Dr Goorens Level 4 hand surgeon
Inclusion criteria:
- Stable distal radial fractures (volar tilt <10° dorsal tilt, <2mm impaction, <2mm articular depression)
- 18 - 65 years, professional active
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of results by computer of the outcome results. Blinding of the patients or the care provider is not possible due to the obvious differences.
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stable distal radial fractures (volar tilt <10° dorsal tilt, <2mm impaction, <2mm articular depression)
- •18 - 65 years, professional active
排除标准
- •associated lesions, open fractures, unstable, displaced fractures
- •neurological disorder affecting the upper limb, history of wrist lesion involving the same wrist, dementia, substance abuse, severe psychiatric disorder and previous injured contralateral wrist
结局指标
主要结局
QALY
时间窗: 1 year
Using the Short Form 36 (SF-36) assessment - cost effectiveness (The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.)
Costs
时间窗: 1 year
Direct, indirect, health insurances
次要结局
- Wrist ROM(1 year)
- PRWE(1 year)
- VAS(1 year)
- DASH(1 year)
- Grip Strength(1 year)
研究者
Goorens Chul Ki
M.D., Principal Investigator
Regionaal Ziekenhuis Heilig Hart Tienen