跳至主要内容
临床试验/NCT00208429
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

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

发起方
DePuy International
申办方类型
Industry
责任方
Sponsor

相似试验