NCT02552082已完成不适用
The Verification Study on the Effectiveness of Rotational Tolerance of Scorpio NRG Study in TKA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Range of motion(ROM)
研究概览
简要总结
The purpose of this study is to evaluate the range of motion (ROM), mid-flexion stability (gap balance), and implant position (size and angle) for the Scorpio NRG device. Relationship between these parameters and clinical outcomes will be evaluated as well as the importance of rotational tolerance. It is expected that the Scorpio NRG will have good clinical outcomes and perform the same or better than other total knee implants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 candidate for primary total knee arthroplasty (TKA).
- •Patient who has diagnosis of osteoarthritis or rheumatoid arthritis.
- •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 and able to comply with postoperative scheduled evaluations.
排除标准
- •Patient who has a bacterial infectious disease or has a risk high of a bacterial infection.
- •Patient who requires revision surgery.
- •Patient who is morbidly obese, defined as having a Body Mass Index (BMI) >
- •Patient who is or may be pregnant female.
- •Patient who has a 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.
结局指标
主要结局
Change in Range of motion(ROM)
时间窗: Pre-operation, intraoperative, 6 months and 1 year after surgery
次要结局
- Change in Japanese Orthopaedics Association (JOA) score,(Pre-operation, intraoperative, 6 months and 1 year after surgery)
- Change in Knee Society Score (KSS)(Pre-operation, intraoperative, 6 months and 1 year after surgery)
研究者
研究点 (1)
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