Outcomes for Robotics in Orthopaedic Trauma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Blood Loss
研究概览
简要总结
Our project aims to integrate whether robotic assistance of reduction and fixation in orthopaedic trauma surgery can enhance accuracy and surgical outcomes. The current study aims to shorten the recovery time and reduce post-operative complications by minimally invasive surgery with robotics.
详细描述
- To assess whether robotic assistance can improve surgical outcomes compared with control group.
- To assess whether robotic assistance can improve fracture reduction compared with control group.
- To assess whether robotic assistance can reduce complication rate compared with control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- 是
入选标准
- •Males or females aged 18 years or older
- •With orthopaedic trauma and fracture
- •Willing to participate in the study
排除标准
- •Cognitive problems e.g., severe dementia (unable to agree for consent)
- •Unable to agree for consent
- •Surgeons decide that surgery is not indicated for the patients
结局指标
主要结局
Blood Loss
时间窗: Baseline
Blood loss will be documented from the Clinical Management System (CMS).
Operation Time
时间窗: Baseline
Operation time will be documented from the Clinical Management System (CMS).
Length of Hospital Stay
时间窗: Baseline
Length of hospital stay will be documented from the Clinical Management System (CMS).
Plain Radiographs
时间窗: From baseline to 52-weeks post-operation
Plain radiographs will be taken at the corresponding sites of injuries post operation. The reduction quality will be assessed based on Matta criteria
Computed Tomography (CT)
时间窗: From baseline to 12-weeks post-operation
CT scan will be taken at the corresponding sites of injuries pre- and post operation.
次要结局
- Quality of life Short Form-36 (SF-36)(From baseline to 52-weeks post-operation)
- Verbal Descriptor Scale(From baseline to 52-weeks post-operation)
- Quadriceps muscle strength(From baseline to 52-weeks post-operation)
- Times Up and Go (TUG) test(From baseline to 52-weeks post-operation)
- Handgrip strength(From baseline to 52-weeks post-operation)
- 5-time chair stand test(From baseline to 52-weeks post-operation)
- Appendicular skeletal muscle mass (ASM)(From baseline to 52-weeks post-operation)
- 6-metre walk(From baseline to 52-weeks post-operation)
- Adverse event and serious adverse event(From 2-weeks post-operation to 52-weeks post-operation)
- Balancing ability(From baseline to 52-weeks post-operation)
研究者
Ronald Man Yeung WONG
Clinical Associate Professor
Prince of Wales Hospital, Shatin, Hong Kong