Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range and Followed for 2 Years.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- FH ORTHO
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Quality of life EQ-5D-5L score
研究概览
简要总结
As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use.
This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.
详细描述
The primary objective of this study is to evaluate the quality of life in patients operated with a FHK® total knee prosthesis up to 2 years of follow-up.
The secondary objectives are to evaluate the security and performance of the devices by gathering complications, revision rate of the devices (survival analysis) and functional score up to 2 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
- •Subject implanted with FHK® 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.
- •Adults subjects (≥18 years old).
- •Access to an internet connection allowing to complete the questionnaires on the online platform
排除标准
- •Contraindications described in the instructions for use
- •Subject who is not able to express his/her non-opposition
结局指标
主要结局
Quality of life EQ-5D-5L score
时间窗: 14 days preoperative ; 70 days post-op, 177 days post-op, 357 days post-op, 717 days post-op
The primary outcome measures will be determined by the EQ-5D-5L score. The EQ-5D-5L score is a self-administered quality of life questionnaire by patients. The EQ-5D-5L consists of two parts, One part with a five-dimensional system and the last one is a visual analog scale graduated from 0 to 100. We will observe the evolution of this score according to the time frame.
次要结局
- Survival rate(2 years post-op)
- Evolution of parameters describing pain, stability, knee mobility and patient autonomy(From the preoperative visit to 2 years postoperative.)
- Rate of complications(All complications will be gathered during intervention and up to 2 years postoperatively.)