Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Functional outcome of the hip revision surgery
研究概览
简要总结
The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem. The study is an observational post-market clinical follow-up study, and the study sites chose the stem variant depending on their own routine and indication.
详细描述
Generally, the advantage of the Prevision implant family is that all implant variants can be implanted with basically the same instrumentation, which makes it easier to switch to another variant. All implant variants will be available at the study sites and switching between the variants in the study will be encouraged.
The aim of the study is to prove the non-inferiority of the OHS functional outcome after two years to the predecessor implant generation, and comparable revision hip stems. In addition, the patient groups treated with the different variants, and outcome of these subgroups will be descriptively compared.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Revision hip arthroplasty patients treated with a Prevision hip stem
- •Written patient informed consent
- •Patients are able to attend at follow-up examinations
排除标准
- •Patients < 18 years at surgery
- •Pregnancy at implantation
- •Patients held in a custodial setting
- •Patients in a relationship of dependence on the sponsor, the clinic or the investigator
结局指标
主要结局
Functional outcome of the hip revision surgery
时间窗: after two years
Oxford Hip Score:The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure designed to assess disability in patients undergoing total hip replacement (THR)
次要结局
- Kaplan-Meier survival(after two years)
- EQ-5D-5L Quality of Life(visits after 2 and 5 years)
- Complications(visits after 2 and 5 years)
- Patient satisfaction(visits after 2 and 5 years)
- Pain (VAS Score)(visits after 2 and 5 years)
- Radiology: Hip stem subsidence(visits after 2 and 5 years)
- Qualitative radiologic assessment(visits after 2 and 5 years)