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临床试验/NCT04711720
NCT04711720Unknown不适用

A Randomized Controlled, Multicenter Study for Patients Underwent Total Hip Arthroplasties Assisted by "VTS"Surgical Navigation System

Peking University Third Hospital0 个研究点目标入组 124 人开始时间: 2021年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
124
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 navigation system. The patients in the control group do not use the surgical navigation 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, range of motion and dislocation rate are the secondaryoutcome 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

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

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

  • Operation time(Immediately after surgery)
  • the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(6 months after surgery)
  • Harris Hip Score (HHS)(6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

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