NCT02524730已完成不适用
Scorpio NRG Prospective, Open-label, Post-market International Multicentre Outcome Study
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
- 205
- 试验地点
- 10
- 主要终点
- Survival Rate
研究概览
简要总结
The purpose of this study is to collect basic function, radiographic and patient satisfaction data for observation and analysis.
详细描述
Evaluation of the effect of the component design on functional performance by comparing postoperative Knee Society Scores (KSS) with preoperative.
Evaluate post-operative radiographic findings. Evaluate the effect of component design on patient activity by comparing postoperative Lower Extremity Activity Scale (LEAS) with preoperative.
Evaluate patient satisfaction using Short-Form-36 Health Survey (SF-36). Evaluate quality of life using Knee Injury and Osteoarthritis Outcome Score (KOOS) and EuroQuol-5 dimension patient questionaire (EQ-5D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is able to understand the meaning of the study and is willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form.
- •The subject is a male or non-pregnant female between 40 and 75 years of age.
- •The subject requires a primary total knee replacement.
- •Patients with osteoarthritis or posttraumatic arthritis (no rheumatoid arthritis)
- •The subject has intact collateral ligaments.
- •The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
- •The subject is capable of understanding the patient scores in the national language.
排除标准
- •The subject is morbidly obese, defined as Body Mass Index (BMI) of >
- •The subject has a history of total or unicompartmental reconstruction of the affected joint.
- •The subject will be operated bilaterally.
- •Patients who had a Total Hip Arthroplasty (THA) on contralateral and/or ipsilateral side within the last year that is considered to have an unsatisfactory outcome (Patients with contralateral and/or ipsilateral THA > 1 year ago with good outcome can be included in the study).
- •Patients who had a Total Knee Arthroplasty (TKA) on contralateral side within the last 6 months that is considered to have an unsatisfactory outcome. (Patients with contralateral TKA > 6 months ago with good outcome can be included in the study).
- •Patients who will need lower limb joint replacement for another joint within one year.
- •The subject has had a high tibial osteotomy or femoral osteotomy.
- •The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
- •The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
- •The subject is immunologically suppressed or receiving steroids in excess of normal physiological requirements.
- •The subject's bone stock in compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
- •The subject has had a knee fusion to the affected joint.
- •The subject has an active or suspected latent infection in or about the knee joint.
- •Proven or suspected hypersensitivity to one or more than one of the device materials (see Appendix 10 table of chemical composition).
- •Female patients planning a pregnancy during the course of the study.
- •The subject is a prisoner.
- •severe deformities: varus/valgus deformity >10° (mech. axis), bowed femur > 20 degree, flexion contracture >10°
研究组 & 干预措施
Scorpio NRG CR Total Knee System
Other
Primary total knee replacement
干预措施: Primary total knee replacement (Scorpio NRG CR Total Knee System) (Device)
结局指标
主要结局
Survival Rate
时间窗: 7 year follow-up
Assess survival (absence of revision) at 7 year follow-up
次要结局
- Investigation of Clinical Performance and Patient Outcome With the Lower Extremity Activity Scale (LEAS) Patient Questionnaire(Pre-operative, 3 months,1, 3, 5 and optional 7 years)
- Investigation of Clinical Performance and Patient Outcome With the Short Form - 36 Health Survey (SF-36)(Pre-operative, 3 months,1, 3, 5 and optional 7 years)
- Investigation of Clinical Performance and Patient Outcome With the EuroQuol-5 Dimension Health Questionnaire (EQ-5D).(Pre-operative, 3 months,1, 3, 5 and optional 7 years)
- Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS)(Pre-operative, 3 months, 1, 3, 5 and optional 7 years)
- Investigation of Clinical Performance and Patient Outcome With the Knee Injury and Osteoarthritis Outcome Score (KOOS) Patient Questionnaire.(Pre-operative,1, 5 and optional 7 years)
研究者
研究点 (10)
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