Computer-Assisted Versus Non-Computer Assisted Preoperative Planning of Corrective Osteotomy for Extra-Articular Distal Radius Malunions: A Multi-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Disability of the Shoulder and Hand Score
研究概览
简要总结
This study is designed as a multi-center randomized controlled trial, comparing two groups of patients with symptomatic extra-articular malunited distal radius fractures. One group of patients will undergo corrective surgery of the distal radius, with preoperative computer-assisted planning and virtual osteotomy, and the other group will undergo corrective surgery, with conventional (non-computer-assisted) preoperative planning. The investigators hypothesize that computer-assisted surgical planning will result in a better functional outcome.
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
- None
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
- •Extraarticular distal radius malunion requiring surgery
- •Adult patient (> 18 yo)
- •Fluent in English
排除标准
- •Pregnant patient
- •Abnormal contralateral forearm
研究组 & 干预措施
Control
Surgery without computer-assisted planning.
干预措施: distal radius osteotomy (Procedure)
Computer-Assisted Surgical Planning
干预措施: Computer-Assisted Surgical Planning (Procedure)
结局指标
主要结局
Disability of the Shoulder and Hand Score
时间窗: 0, 3, 6, 12 months
DASH score is a measure of upper extremity function. It ranges 0-100, where higher scores indication more disability and worse upper extremity function.
次要结局
- Patient-Rated Wrist Evaluation (PWRE_(0, 3, 6, 12 months)
- Numerical Rating Scale for Satisfaction(0, 3, 6, 12 months)
- Numerical Rating Scale for Pain(0, 3, 6, 12 months)
研究者
Jesse B. Jupiter, MD
Principal Investigator
Massachusetts General Hospital