NCT00208403终止4 期
Randomised, Prospective, RSA, PMS Study Comparing Acryloc™ & Palacos R in Primary Total Hip Arthroplasty
DePuy International1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2002年10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
- 36
- 试验地点
- 1
- 主要终点
- Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment
研究概览
简要总结
The purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, Acryloc™ and Palacos® R, in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to Acryloc™ or Palacos® R and will be evaluated at regular intervals following hip surgery using patient, clinical, x-ray assessments and special x-rays which allow the stability of the hip implant to be determined
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
- 60 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 60 to 75 years (inclusive), and with a weight of less than 100kg.
- •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 with non-inflammatory arthritis of the hip.
- •v) Subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the Investigational Centre.
- •vi) Subjects who are considered suitable for a cemented femoral stem and cemented acetabular component.
排除标准
- •i) Subjects who, in the opinion of the Investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other 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 undergoing corticosteroid treatment.
- •vii) Subjects with any condition for whom the use of conventional bone cement is contra-indicated.
结局指标
主要结局
Distal migration of the femoral prosthesis from the time of implantation to the 2 year follow-up assessment
时间窗: 2 Year
次要结局
- Radiographic analysis(Annually)
- Kaplan-Meier Survivorship - Revision of any component for any reason(Throughout Study)
- Annual posterior (AP) and medio-lateral (ML) RSA translations(Annually)
- Merle D'Aubigne score(Annually)
研究者
研究点 (1)
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