NCT04221581进行中（未招募）不适用
Prospective Observational Clinical Study Conducted on Patient Operated With a Total Knee Prosthesis FHK ASYMETRIQUE to Confirm Security and Performance of the Device Over a Period of 10 Years
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- FH ORTHO
- 入组人数
- 43
- 试验地点
- 3
- 主要终点
- Safety evaluation
研究概览
简要总结
This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the FHK asymetrique prosthesis, which is intended to be implanted in case of total knee replacement, when used in real life conditions according to the instructions for use.
详细描述
The primary objective of this study is to evaluate the security of the FHK ASYMETRIQUE prosthesis by calculating the survival rate up to 10 years of follow-up.
The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score up to 10 years of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults subjects (≥18 years old).
- •Subject implanted with FHK ASYMETRIQUE prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
- •Subject who received an information form and is willing to participate in the study.
排除标准
- •Contraindications described in the instructions for use
- •Usual surgical contraindications
- •Patients objecting to participate in this study
- •Subject who is not able to express his/her non-opposition
结局指标
主要结局
Safety evaluation
时间窗: 10 years post-op
Survival rate
次要结局
- Radiological evaluation(preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op)
- Rate of complications(peroperative, 3 months postoperative, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op)
- Functional outcomes such as pain, mobility.(preoperative, 3 months post-op, 1 year post-op, 3 years post-op, 5 years post-op, 10 years post-op)
研究者
研究点 (3)
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