NCT01134445终止4 期
Prospective, International Multi-centre, Uncontrolled, Post Marketing Surveillance Study to Monitor the Long-term Performance of the DePuy PROXIMA™ Hip in Subjects With Indications Suitable for a Primary Total Hip Arthroplasty
DePuy International4 个研究点 分布在 4 个国家目标入组 42 人开始时间: 2010年2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
- 42
- 试验地点
- 4
- 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 DePuy PROXIMA™ hip 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
- •Male or female subjects between 18 and 70 years of age.
- •Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- •Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and agree to return to the hospital for all the required post-operative follow-ups.
- •Subjects who are scheduled to undergo a primary THR whom the surgeon considers to be suitable for the DePuy PROXIMATM hip femoral prosthesis.
排除标准
- •Subjects with active local or systemic infection
- •Subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.
- •Subjects with poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).
- •Subjects with Charcot's or Paget's disease.
- •Subjects with hip dysplasia with severe neck anteversion or severe dysplasia of the proximal femur.
- •Subjects with severe osteoporosis.
- •Subjects with previous proximal femoral fractures.
- •Subjects who, in the opinion of the Investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study.
- •Women who are pregnant.
- •Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- •Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).
- •Subjects who are currently involved in any injury litigation claims.
- •Subjects for whom the surgical procedure is a revision of a previous THR, hemi-arthroplasty or hip resurfacing
- •Subjects who have previously undergone osteotomy or arthrodesis of the hip.
- •Subjects undergoing a simultaneous bilateral hip operation.
- •Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation.
- •Subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily
结局指标
主要结局
Kaplan-Meier survivorship calculated at the five-year time-point
时间窗: 5yrs post surgery
次要结局
- Annual Kaplan-Meier survivorship calculations(15yrs post-surgery)
- Harris Hip Score(15yrs post-surgery)
- Oxford Hip Score(15yrs post-surgery)
- UCLA Activity Score(15yrs post-surgery)
- Hip Outcome Score(15yrs post-surgery)
- EuroQol EQ-5D(15yrs post-surgery)
- Radiographic Analysis(15 yrs post-surgery)
研究者
研究点 (4)
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