Study of the Total Hip Prosthesis With a HYPE Stem in Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Survival rate
研究概览
简要总结
The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution.
This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.
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
- •Degenerative or inflammatory hip disease requiring total hip replacement
- •Primary or secondary osteoarthritis,
- •Advanced joint destruction resulting from rheumatoid arthritis or traumatic origin,
- •Avascular fracture or necrosis,
- •Displaced subcapital and transcervical fracture as well as PAPROSKY stages I to IIB bone defects.
- •Joint destruction of traumatic origin
- •Following a previous operation, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, total arthroplasty).
排除标准
- •Patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up
- •Known pregnancy in progress
- •Breastfeeding
- •Patient requiring a bone graft
- •Neurological disorders or other pathology that may influence locomotion
- •History of sepsis in the hip to be operated on
- •Short-term vital prognosis
结局指标
主要结局
Survival rate
时间窗: Per operative period to 10 years
Survival rate for failure at 10 years by studying in particular the intraosseous behaviour of the stem (femoral implant) and of the acetabulum (acetabular or acetabular implant) with the help of radiological examinations: appearance or not of lines, osseointegration, migration, possible loosening, realignment.
次要结局
- Patient satisfaction(Per operative period to 10 years)
- Pain release(Per operative period to 10 years)
- Functional improvement(Per operative period to 10 years)
- Adverse event(Per operative period to 10 years)