Prospective and Observational Study of HYPE SCS Stems
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Survival rate according to Kaplan-Meier
研究概览
简要总结
Total hip arthroplasty is the preferred treatment for hip disease (primary or secondary osteoarthritis, osteonecrosis, for example) and femoral neck fractures.
HYPE SCS stems are intended to be used for primary total hip arthroplasties to reduce pain and restore joint mobility of the hip.
Clinical data for HYPE SCS available are not deemed sufficient to support performance and benefits claimed on the whole lifetime of the product.
Thus, in order to maintain compliance with the EU regulation (2017/745) relating to medical devices and following MEDDEV 2.7.1.guidelines, SERF has set up post-market clinical follow-ups (PMCF). This PMCF study aims to generate clinical data in order to confirm these performance of HYPE SCS Stem associated to NOVAE Sunfit TH acetabular cup. In the meantime, through complications faced over the entire period of the study, risks related to the implantation of HYPE SCS stems will be assessed at medium term (5 years). It should be noted that this patient cohort reflects the usual medical care of Hospital Center "J. Monod" of Flers.
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
- •Patients over 18 years old.
- •Patients covered by health insurance system
- •Patients requiring a total hip arthroplasty, implanted swith a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup
排除标准
- •Patient who expressed opposition to participation in the study and to the use of his personal data
- •Patient unable to understand surgeon's instructions and meet follow-ups requirements
- •Patient presenting a contraindication indicated in the IFU of both implantsw
- •Patient presenting a contraindication to have an X-ray
- •Patients implanted with a femoral stem SCS associated to NOVAE Sunfit TH acetabular cup, in context of off-label use
结局指标
主要结局
Survival rate according to Kaplan-Meier
时间窗: per operative period to 5 years
whatever the cause of revision
次要结局
- Pain release(per operative period to 5 years)
- Adverse events(per operative period to 5 years)
- Patient satisfaction(per operative period to 5 years)
- Functional improvement(per operative period to 5 years)