NCT00872066已完成4 期
A Prospective, Randomised, Uncontrolled, Single-Centre, Post-Market Surveillance Study To Evaluate The Performance Of SmartSet® HV and SmartSet® GHV Bone Cements In Primary Cemented Total Hip Arthroplasty(THA)
DePuy International1 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2006年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Kaplan-Meier survivorship
研究概览
简要总结
The purpose of this study is to monitor the performance of artificial hip joints implanted with two different bone cements, SmartSet® HV and SmartSet® GHV, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to SmartSet® HV or SmartSet® GHV and 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 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 75 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 requiring primary total hip arthroplasty and are considered suitable for a cemented femoral component.
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) Women who are pregnant.
- •iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- •iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- •v) Subjects who are currently involved in any injury litigation claims.
- •vi) Subjects with contraindications normally applicable to the use of conventional bone cement, in accordance with the manufacturer's Instructions For Use.
结局指标
主要结局
Kaplan-Meier survivorship
时间窗: Annually
次要结局
- Oxford Hip Score(Annually)
- Radiological Analysis(Annually)
- Harris Hip Score(Annually)
研究者
研究点 (1)
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