Hip Prospective Study: Long-term Post-market Clinical Follow-up on the Use of SERF Hip Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
In an evaluation report dated 2014, the HAS (Haute Autorité de Santé -French National Authority for Health) highlights that long-term clinical data on hip prostheses are needed in the context of the French healthcare system. In addition, per the European Regulation 2017/745, medical devices manufacturers shall conduct Post-Market Clinical Follow-up (PMCF) on their devices or provide a justification why PMCF is not applicable.
Therefore, as part of the PMCF process of their hip prostheses, SERF wants to conduct a PMCF investigation to ensure the long-term real-life performance, safety and benefits of these prostheses.
HiPS is a non-comparative, prospective, multicentric, national, 15-year follow-up clinical investigation.
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
- •Male or female adults
- •Planned to be implanted with investigational medical devices per the IFUs:
- •Implantation in skeletally mature adults (usually aged 60-65 and over), with an extremely painful and/or disabled joint and insufficiently improved by alternative treatment options after an observation period lasting from a few weeks to a few months
- •Implantation of investigational medical devices as integrated systems (all components from SERF, no component from another manufacturer)
- •For an intended purpose and indication listed in the IFUs
- •Affiliated to French social security
- •Who provided a dated and signed informed consent form
排除标准
- •Patient protected by a French legal measure
- •Patient not able to express his/her consent as deemed by the investigator
- •Patient deprived of liberty or hospitalized without consent
- •Pregnant or breastfeeding women
- •Patient contraindicated to investigational medical devices implantation per the IFUs
- •Patient contraindicated to radiographic follow-up
- •Patient a priori not able to meet the follow-up visits as deemed by the investigator
- •Patient not able to fulfil a self-assessment questionnaire as deemed by the investigator.
结局指标
主要结局
Survival rate
时间窗: Per operative period to 15 years
To assess the survival rate of the investigational medical devices at the end of their claimed implantation duration
次要结局
- Adverse events(Per operative period to 15 years)
- Functional improvement(Per operative period to 15 years)
- Patient's quality of life(Pre operative period to 15 years)
- Patient's satisfaction(Post operative period to 15 years)
- Leg length discrepancy(Pre operative period to 15 years)
- Patient's Pain(Pre operative period to 15 years)
- Intermediate survival rates(Per operative period to 10 years)
- Surgeon's satisfaction(Per operative period to 15 years)