Metal-on-metal Hip Prostheses: Do They Have Systemic Effects?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800,000
- 试验地点
- 1
- 主要终点
- Heart failure
研究概览
简要总结
This study aims to determine whether subjects who underwent large-diameter metal-on-metal hip arthroplasty are more likely to have developed heart failure or other conditions as compared to subjects with conventional hip replacements.
We plan to link the National Joint Registry for England, Wales and Northern Ireland to the National Heart Failure Audit and GP records.
详细描述
Background: Chronic systemic exposure to very high concentrations of cobalt or chromium following large diameter metal-on-metal hip resurfacing or hip replacement (MOMHR) associates with cardiac, thyroid, visual, hearing, and peripheral neurological deficits. Chronic exposure to lower circulating metal levels also associates with changes in cardiac function and bone metabolism in case-control analyses. However, it remains unclear what the risk of these problems is in the general population exposed to MOMHR.
Aims: We aim to establish the prevalence of cardiac, endocrine, neurological disorders, and distant site fracture history (forearm, spine) in recipients of MOMHR, and establish whether this differs to that found in the general population of the same age and sex distribution, and also to recipients of hip replacement using a conventional bearing.
Methods: We will use NJR data linked to the Clinical Practice Research Dataset (CPRD) to establish the prevalence of cardiac, endocrine, neurological disorders, and distant site fracture history (forearm, spine) in the 3 study populations.
Outcome measures: All defined as the event occurring at any point following MOMHR surgery.
Primary outcome measure:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acceptable patients registered with an up to standard practice which participates in the CPRD linkage scheme.
- •Have at least 6 (or 12) months of valid follow up in the primary care database.
- •Primary or revision hip replacement on National Joint Registry (NJR) database occurring to during the period of availability of metal-on-metal implants, and during the available primary care follow up period for that patient.
- •NHS number and other linkage identifiers available for both data sources
- •Patient consent to NJR use of patient data (which is present for 99.6% of records on NJR)
排除标准
- •Procedures on NJR database performed in Wales, Scotland and Northern Ireland (as these areas are not been included in the CPRD linkage scheme)
- •Patients whose hips were implanted in the past 6 months - this exclusion criterion will be implemented post linkage of the data.
结局指标
主要结局
Heart failure
时间窗: 6 months onwards
次要结局
- Acquired neurological disorders, including extra-pyramidal disorders spinocerebellar degenerative disease and other paralytic syndromes(6 months onwards)
- Acquired hearing loss(6 months onwards)
- History of treated or untreated acquired hypothyroidism or equivalent(6 months onwards)
- Fracture history at a site distant to the ipsilateral hip(6 months onwards)
- Acquired blindness and low vision(6 months onwards)
研究者
Professor Alister Hart
Professor of Orthopaedics
Royal National Orthopaedic Hospital NHS Trust