Multicentre, Observational Study Evaluating the Clinical and Radiological Outcomes of Hip Arthroplasty Using the Dual Mobility Cup
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Primary Osteoarthritis
- 发起方
- Stryker Trauma and Extremities
- 入组人数
- 379
- 主要终点
- Number of Participants With an Implant Dislocation After Surgery
- 状态
- 已完成
- 最后更新
- 9年前
概览
简要总结
The purpose of this study is to demonstrate the performance and reliability of Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at least 24 months post-insertion.
详细描述
The PURPOSE of this study is to demonstrate the performance and reliability of the Tornier "Dual Mobility Cup" used during primary total hip replacement or hip replacement revision surgery at a minimum of 24 months post-implantation. The primary endpoint is to determine the dislocation rate observed during post-surgical follow-up. The secondary endpoints are to assess, in the short-term, the following: clinical performance on the basis of clinical scores and hip mobility; radiological performance, particularly in terms of positioning and fixation of the implant; as well as the reliability of the implantation of this acetabular cup on the basis of any complications observed
研究者
入排标准
入选标准
- •men and women aged over 18, undergoing total hip replacement with insertion of a Dual Mobility acetabular cup between October 2010 and October 2011,
- •capable of attending the 2-year follow-up visit;
- •capable of understanding the information about the study and agreeing to take part in it.
排除标准
- •patients with tumoral pathology.
结局指标
主要结局
Number of Participants With an Implant Dislocation After Surgery
时间窗: 2-year postoperative
The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.
Percentage of Participants With an Implant Dislocation After Surgery (= Dislocation Rate)
时间窗: 2-year postoperative
The primary safety outcome (implant dislocation) was assessed by a single question to the patients : Did you experience any implant dislocation since your surgery ? Positive answers were quantified.
Implant Survivorship
时间窗: 2-year postoperative
Implant survivorship criteria was assessed by investigators during patients visits : is the implanted device still in place 2 years after surgery ? Negative answers were quantified.
次要结局
- Clinical Performance - PMA Score(2 years postoperative)
- Clinical Performance - HOOS Score(2 years postoperative)
- Clinical Performance - HARRIS Score(2-year postoperative)