NCT00208390终止4 期
Prospective, Uncontrolled, Multi-Centre, Post-Marketing Surveillance Study to Evaluate the Long-Term Performance of Summit Tapered Hip in Cementless Total Hip Arthroplasty
DePuy International6 个研究点 分布在 6 个国家目标入组 275 人开始时间: 2003年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 275
- 试验地点
- 6
- 主要终点
- Kaplan-Meier survivorship calculated at the five-year time point
研究概览
简要总结
The purpose of this study is to monitor the performance of the Summit™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •i) Male or female subjects, aged between 18 and 70 years (inclusive).
- •ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- •iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- •iv) Subjects who require primary total hip replacement and are considered suitable for a cementless femoral stem.
排除标准
- •i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- •ii) Subjects who have previously undergone a hemi-arthroplasty or total hip arthroplasty.
- •iii) Women who are pregnant.
- •iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- •v) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
- •vi) Subjects who are currently involved in any injury litigation claims.
结局指标
主要结局
Kaplan-Meier survivorship calculated at the five-year time point
时间窗: 5yrs post-surgery
次要结局
- Harris Hip score(6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery)
- UCLA activity rating(6mths and Annually post-surgery)
- Kaplan-Meier survivorship calculations(Annually)
- Thigh pain analysis(6mths and Annually post-surgery)
- Oxford score(6mths and Annually post-surgery)
- Radiological analysis(pre-discharge, 6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery)
研究者
研究点 (6)
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