Operative vs. Conservative Treatment of Distal Radius Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of participants with treatment-related complications at baseline
研究概览
简要总结
Even though broken wrists are of frequent occurrence, the investigators see a lack of extensive and well executed international studies to clarify which is the best treatment for elderly participants at 65+ years. The Danish Health and Medicines Authority recommend that broken wrists are treated with surgery by using plates and screws when certain radiological criteria are met. Recent studies show that, apparently, there are no advantages by operating rather than treating with plaster when comparing the functional results after one year. However, there is a 30 % risk of serious complications occurring after surgery. This study will examine the pros and cons that participants at 65+ years with broken wrists experience after, by lot, having been treated with either surgery (using plates and screws) or without surgery (using plaster for 5 weeks). The purpose of this study is to compare the complications and level of functioning between participants treated with surgery and without surgery.
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 (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Danish National Guidelines for operative treatment of distal radius fractures
排除标准
- •Patients treated with plaster in Arm1/control group who unexpectedly requires surgery
结局指标
主要结局
Number of participants with treatment-related complications at baseline
时间窗: Baseline
Change in number of participants with treatment-related complications from baseline at 1 year
时间窗: 1 Year
Range of motion of the wrist at week 5
时间窗: Week 5
a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)
Change in number of participants with treatment-related complications from baseline at week 2
时间窗: Week 2
Change in range of motion of the wrist from month 6 at 1 year
时间窗: 1 Year
a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)
Change in number of participants with treatment-related complications from baseline at week 5
时间窗: Week 5
Change in number of participants with treatment-related complications from baseline at month 6
时间窗: Month 6
Change in range of motion of the wrist from week 5 at month 6
时间窗: Month 6
a. Flexion (0-90 degrees) b. Extension (0-75 degrees) c. Pronation (0-90 degrees) d. Supination (0-90 degrees) e. Radial flexion (0-25 degrees) f. Ulnar flexion (0-50 degrees)
Level of functioning at baseline
时间窗: Baseline
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at week 2
时间窗: Week 2
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at week 5
时间窗: Week 5
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at month 6
时间窗: Month 6
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
Change in level of functioning from baseline at 1 year
时间窗: 1 Year
Using QuickDASH (Quick Disabilities of the Arm, Shoulder, and Hand)
次要结局
未报告次要终点