A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS" Surgical Robotic System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Acetabular location accuracy
研究概览
简要总结
This is a randomized controlled, multicenter study. According to the inclusion criteria, volunteers were recruited from patients undergoing total hip arthroplasty. After signing the informed consent, the subjects were assigned to the experimental group and the control group through the central randomization system. The researchers will complete the total hip arthroplasty for patients in the experimental group with the assistance of surgical robotic system. The patients in the control group do not use the surgical robotic system. The proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is the primary outcome measurement. The operation time, WOMAC score, Harris score, SF-36 and dislocation rate are the secondary outcome measurements. The incidence of complications, devices and other adverse events were recorded.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary hip osteoarthritis(OA), fracture of femoral neck (FFN),or secondary hip osteoarthritis due to developmental dysplasia of the hip (DDH), hip avascular necrosis (AVN), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and coxa plana
排除标准
- •Severe vascular diseases of the lower extremity Neuromuscular diseases Infectious diseases Severe dysfunctions of major organs Severe neurosensory deficiencies caused by spinal diseases Unable to receive CT/MRI scans
研究组 & 干预措施
robotic
干预措施: "VTS" surgical robotic system (Device)
Control
结局指标
主要结局
Acetabular location accuracy
时间窗: Within 1 week after surgery
Proportion of abduction angle and anteversion angle of acetabular cup in lewinnek safe area
次要结局
- the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(6 months after surgery)
- adverse events or complications(6 months after surgery)
- 36-Item Short Form Survey (SF-36）(6 months after surgery)
- dislocation rate of hip joint(6 months after surgery)
- Operation time(Immediately after surgery)
- Harris Hip Score (HHS)(6 months after surgery)