NCT00872573终止4 期
Prospective, Uncontrolled, Two-centre, RSA, Post-market Surveillance Study to Evaluate the Stability of the C-Stem™ AMT Femoral Component in Primary Total Hip Arthroplasty.
DePuy International1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2006年7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
- 5
- 试验地点
- 1
- 主要终点
- Distal migration of the femoral stem at the 5-year time point
研究概览
简要总结
The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh bone when used 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, standard x-ray assessments and special x-rays which allow the stability of the implant 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
- 60 Years 至 80 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 60 and 80 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 that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup.
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 replacements.
- •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
Distal migration of the femoral stem at the 5-year time point
时间窗: 5 years
次要结局
- Harris Hip score(3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery)
- Oxford Hip score(3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery)
- Radiological analysis(3mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery)
- ML/AP translation and all rotations out to 5 years(pre-discharge, 3mths, 6mths, 1yr, 18mths, 2yrs, 3yrs and 5yrs post-surgery)
研究者
研究点 (1)
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