NCT00208364终止4 期
Uncontrolled Prospective Multi-Centre Post Marketing Surveillance Study to Monitor the Long Term Survivorship of Pinnacle Acetabular Cup Prosthesis With a Metal on Metal Bearing in Subjects With Aetiologies Requiring a Primary Total Hip Replacement
DePuy International2 个研究点 分布在 2 个国家目标入组 163 人开始时间: 2004年4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
- 163
- 试验地点
- 2
- 主要终点
- Kaplan-Meier survivorship calculated at the 5 year time point.
研究概览
简要总结
The purpose of this study is to monitor the performance and determine the metal ion release of the Pinnacle™ Cup with a metal-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. A subset of patients will also have blood samples taken at regular intervals to allow the metal ion levels to be determined.
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 cementless acetabular components.
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) Women who are pregnant.
- •iv) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect 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.
- •Additional Exclusion Criteria for Subjects Having Blood Analysis:
- •Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties unless known to be pure titanium or titanium alloy.
- •Subjects with an occupational exposure to cobalt or chromium.
- •Subjects who have ingested medication or vitamins containing cobalt or chromium within the last 12 months.
- •Subjects who, in the opinion of the Investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
- •Subjects who are undergoing a simultaneous bilateral total hip replacement.
结局指标
主要结局
Kaplan-Meier survivorship calculated at the 5 year time point.
时间窗: 5 years
次要结局
- Harris Hip score(6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery)
- Radiological analysis(6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery)
- Annual Kaplan-Meier survivorship calculationsMetal ion analysis in whole blood(Annually)
- Oxford Hip score(6mths, 1yr, 2yrs, 3yrs, 5yrs, 7yrs 10yrs and 15yrs post-surgery)
- Metal ion analysis in whole blood(pre-discharge, 6mths, 1yr, 2 yrs and 5yrs post-surgery)
研究者
研究点 (2)
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