NCT02543463已完成不适用
Comparison X3 Study Between Navi-THA and Non-navi-THA
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Range of motion (ROM) during surgery
研究概览
简要总结
The purpose of this study is to compare the effect of the large head in THA with a navigation system and without a navigation system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who is a candidate for a primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
- •Patient who has a diagnosis of degenerative joint disease and no bacterial infectious disease.
- •Patient who is age 20 or over.
- •Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
- •Patient who is willing to and able to comply with postoperative scheduled evaluations.
排除标准
- •Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
- •Patient who requires revision surgery of a previously implanted total hip arthroplasty.
- •Patient who is morbidly obese, defined as having a Body Mass Index (BMI) >
- •Patient who is or may be pregnant female.
- •Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
- •Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
- •Patient who is immunologically suppressed or receiving chronic steroids.
- •Patient who is judged ineligible with specific reason by primary doctor.
研究组 & 干预措施
With Navigation system
Other
Large diameter head with Trident X3 insert with Navigation system
干预措施: Trident X3 Insert with Navigation system (Device)
Without Navigation system
Other
Large diameter head with Trident X3 insert with conventional instrumentation
干预措施: Trident X3 Insert with conventional instrumentation (Device)
结局指标
主要结局
Range of motion (ROM) during surgery
时间窗: intraoperative
次要结局
- Measuring accuracy of the ROM during surgery(Intraoperative)
- Postoperative dislocation(From intraoperative to 1yr)
- implantation accuracy(Intraoperative)
研究者
研究点 (2)
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