NCT03224689Unknown不适用
A Multi-Centre Clinical Investigation To Evaluate The Safety And Performance Of The Freedom Total Knee® System With The PEEK-OPTIMA Femoral Component
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Knee Society Score (KSS)
研究概览
简要总结
Prospective, multi-centre, non-comparative, post-market surveillance clinical study
详细描述
PRIMARY ENDPOINT:
- The primary endpoint is to evaluate the procedural success ie successful implantation of the device in the opinion of the surgeon
SECONDARY ENDPOINTS:
The secondary endpoints are to evaluate:
- KSS Knee scores and KSS Function scores at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
- Subject reported outcomes (SF-36, Oxford Knee Score and WOMAC) at 6 weeks, 6, 12 and 24 months post-treatment compared to pre-treatment
- Stability of the device through radiographic analysis to assess alignment and component position at immediate post-treatment, 6 weeks, 6, 12 and 24 months post-treatment
- Safety in terms of adverse events and device deficiencies throughout the clinical investigation including any additional knee treatments and/or surgery
- Survivorship analysis of the device at 12 and 24 months and annually thereafter
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Knee Society Score (KSS)
时间窗: Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months
Pre-and post-operative function and patient and mechanical assessment. The KSS contains questions in 2 sections: knee joint (pain, range of motion, stability) and function (walking distance, ability to climb stairs). The greater score correlates to better outcome.
次要结局
- SF-36(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
- Visual Analog Scale (VAS)(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
- Radiographic assessment(Change from Pre-op versus 6 weeks, 3 months, 6 months,12 months and 24 months)
研究者
研究点 (1)
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