Short vs Long Arm Cast for Distal Radius Fractures: the Verona Trial. Randomized Clinical Trial to Assess the Efficacy of Short Arm Cast Versus Long Arm Cast in Conservative Management of Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353
- 试验地点
- 2
- 主要终点
- Secondary displacement ratio
研究概览
简要总结
This study prospectively compares the performance of an above-elbow cast (long arm cast) and a below-elbow cast (short arm cast) to maintain reduction in conservatively managed distal radius fractures.
详细描述
The choice of cast length in conservative management of distal radius fractures still represents a much debated controversy. Classic teaching was to immobilize the elbow to reduce risk of secondary displacement; however, short arm casts are felt to be equally effective with less complications and higher patient comfort. There is currently no conclusive evidence for or against immobilization of the elbow in patients treated with cast immobilization.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of distal radius fracture
- •Indication to conservative treatment
- •Need for manipulation to reduce fracture
排除标准
- •Open fractures
- •Existence of any skin lesion or wound that would impair cast treatment
- •Neurovascular deficits
- •Bilateral fractures
- •Association with any other fracture of the homolateral arm
结局指标
主要结局
Secondary displacement ratio
时间窗: 35 days
Percentage of fractures that displace during treatment as subjectively assessed on radiographs by investigators.
Variation of radial length
时间窗: 35 days
Difference between radial length values as objectively measured on postreduction radiographs and endtreatment radiographs.
Variation of radial inclination
时间窗: 35 days
Difference between radial inclination values as objectively measured on postreduction radiographs and endtreatment radiographs.
Variation of volar tilt
时间窗: 35 days
Difference between volar tilt vaues as objectively measured on postreduction radiographs and endtreatment radiographs.
次要结局
- Post-treatment elbow range of motion (ROM)(35 days)
- SF-12(35 days)
- DASH score(35 days)
研究者
Tommaso Maluta
Principal Investigator
Azienda Ospedaliera Universitaria Integrata Verona