NCT00208429撤回4 期
Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup System With a Metal on Enduron Polyethylene Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement
DePuy International0 个研究点开始时间: 2004年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 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 Pinnacle™ Cup with a polyethylene-on-metal bearing combination 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 undergoing primary total hip replacement who are suitable for a cementless acetabular component and a metal on polyethylene bearing.
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 undergoing revision hip replacement.
- •iii) Subjects undergoing simultaneous bilateral hip operation.
- •iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.
- •v) Women who are pregnant.
- •vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months.
- •viii) 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: 5 yrs post surgery
次要结局
- Change in Baseline to post-operative assessment in clinical outcome using the Harris Hip Score(6mths, 1yr, 2yrs, 5yrs, 7yrs, 10yrs and 15yrs post-surgery)
- Kaplan-Meier survivorship(Annually up to 15 yrs post-surgery)
- Change in Baseline to post-operative assessment in clinical outcome using the Oxford Hip Score(Annually up to 15 yrs post-surgery)
研究者
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