Survivorship and Patient Outcomes of Primary Total Hip Arthroplasty With the Ovation Hip System
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Survivorship - The number of revision surgeries over time.
研究概览
简要总结
The objective of this study is to evaluate patient outcomes in regards to safety and effectiveness based on the clinical performance of the reference devices to further support the assessment of residual risk identified in the Clinical Evaluation Report for the Ortho Development Hip System.
详细描述
Long term surveillance of survivorship and complications can help to identify pre-surgical comorbidities, perhaps leading to a lower risk of implant failure and subsequent revision surgery. By understanding the role of comorbidities in the specific population, it is possible to increase patient outcomes and satisfaction, while reducing the costs associated with complications and revision surgeries.
This study consists of prospective collection and analysis of data for a consecutive series of patients that underwent total hip arthroplasty with the Ortho Development Ovation® Hip System at the study site between 2012 and December 2015. It is estimated that over 400 patients received the subject system. Each of these patients will receive a survey within the mail when they approach, or have exceeded, their five-year post-surgical time period.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years of age
- •Patient is five years post total hip arthroplasty
- •Patient received the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
- •Patient agrees to participate in the survey.
排除标准
- •Patient does not have the Ovation® or Ovation Tribute® femoral stem with associated acetabular and femoral components
结局指标
主要结局
Survivorship - The number of revision surgeries over time.
时间窗: 5 - 10-year follow-up
The primary outcome will be 5-10 year survivorship of implant components, with failure defined as revision of any component.
次要结局
- General Health(5 - 10 year follow-up)
- Patient satisfaction.(5 - 10 year follow-up)
- Pain and Function(5 - 10 year follow-up)