NCT00873444终止4 期
Randomised, Controlled, Prospective, Multi-Centre, Post Market Surveillance Study Comparing a Ceramic-on-Metal Bearing and a Metal-on-Metal Bearing in Subjects Requiring Primary Total Hip Arthroplasty for Non-Inflammatory Degenerative Joint Disease
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
- Cobalt metal ion levels in the blood at 2 years post surgery
研究概览
简要总结
The purpose of this study is to monitor the performance and compare the metal ion release of two bearing combinations, ceramic-on-metal and metal-on-metal in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the bearing combinations and will be evaluated at regular intervals using, patient, clinical and x-ray assessments. Patients will also have blood samples taken at regular intervals to allow the metal ion levels 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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature male or female subjects, aged between 20 and 75 years inclusive at the time of surgery.
- •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 are willing to return to the hospital for all the required post-operative follow-ups.
- •Subjects undergoing unilateral primary total hip replacement who are suitable for a cementless acetabular component and whose femoral and acetabular bone stock is suitable to receive implants, without the requirement for a bone graft.
- •Subjects with radiographic evidence and primary diagnosis of non-inflammatory degenerative joint disease (NIDJD).
- •Subjects with a pre-operative Harris Hip Score of less than or equal to 70 and a pain rating of at least moderate for the operative hip.
排除标准
- •Subjects who, in the opinion of the Investigator, have an existing condition, such as active infections, highly communicable diseases, neurological or musculoskeletal disorders that might affect weight-bearing and metastatic or neoplastic disease, that would compromise their participation and follow-up in this study.
- •Subjects who currently have other metallic foreign bodies including trauma products and joint arthroplasties, unless known to be titanium alloy only.
- •Patients who have received a total hip arthroplasty in the contralateral hip within the previous 12 months unless known to be titanium alloy only.
- •Subjects who have undergone previous hip surgery on the operative hip (including previous hip/surface replacements, resection arthroplasty or surgical fusion of the hip).
- •Subjects requiring a simultaneous bilateral hip operation.
- •Subjects who, in the opinion of the investigator, will possibly require a separate joint replacement operation within the next two years, including revision operations.
- •Subjects with an acute femoral neck fracture of the operative hip.
- •Subjects who have undergone above knee amputation of the contralateral and/or ipsilateral leg.
- •Subjects with compromised renal function.
- •Subjects with a known allergy to metal (eg, jewellery).
- •Subjects with an occupational exposure to cobalt, chromium, molybdenum, titanium or nickel.
- •Subjects who have ingested medication or vitamins containing cobalt, chromium, molybdenum, titanium or nickel within the last 12 months, or intend to ingest such substances over the next 2 years.
- •Subjects who have undergone systemic steroid therapy, excluding inhalers, in the three months prior to surgery.
- •Women who are pregnant.
- •Subjects who are prisoners, 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 12 months.
- •Subjects who are currently involved in any injury litigation claims.
结局指标
主要结局
Cobalt metal ion levels in the blood at 2 years post surgery
时间窗: 2 years post-surgery
次要结局
- Harris Hip Score(6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery)
- Blood metal ion levels(pre-discharge, 6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery)
- Kaplan-Meier survivorship calculations(Annually)
- UCLA Score(6 weeks, 6 months, and Annually)
- Pain Visual Analogue Scale(6 weeks, 6 months, and Annually)
- Oxford Hip Score(6 weeks, 6 months, and Annually)
- Radiographic analysis(6 weeks, 6mths, 1yr, 2yrs, 5yrs and 10yrs post-surgery)
研究者
研究点 (1)
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