The Rate of Symptomatic and Asymptomatic Non-malignant, Non-infective Soft Tissue Masses in Primary Metal on Metal Hip Replacement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MRI Scoring change in soft tissue mass size
研究概览
简要总结
This study is being conducted to determine the rate of symptomatic and asymptomatic nonmalignant, noninfective soft tissue mass presence (referred to in the literature as pseudotumour, ALVAL, ARMD, cysts or lesions) in primary metal on metal hip replacement patients. The primary objective of the study is to determine the prevalence of masses in unbiased Metal on Metal (MoM) samples drawn from one study centre. The subjects receiving the Metal on Metal devices will be observed at two specific time points. Secondary objectives are to evaluate whether the occurrence of masses is related to any of several potential factors including patient and implant characteristics and time since the implant procedure took place.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients implanted with the M2a Magnum who were evaluated via MRI and metal ion analysis between 2012 and 2013.
排除标准
- •If the primary device was implanted for less than 36 months (in the case of patients already revised) or has been in place for less than 36 months (in the case of patients with the device still in place).
- •If the patient is contraindicated for any of the diagnostic tests.
- •If the patient fails to consent to participating in the study.
结局指标
主要结局
MRI Scoring change in soft tissue mass size
时间窗: 36 months after primary device implantation
MRI Score - monitor number and size of soft tissue lesions
次要结局
- Radiographic assessment(36 months after primary device implantation)
- Oxford Hip Score(36 months after primary device implantation)
- UCLA Activity Score(36 months after primary device implantation)
- EQ-5D(36 months after primary device implantation)
- Metal Ion Levels(36 months after primary device implantation)