Whole Blood Metal Ion Concentrations in Metal-on-metal Total Hip Arthroplasty and Hip Resurfacing - A Randomized Controlled Trial With 5-years Follow up Including 75 Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 75
- 主要终点
- Metal Ion Concentrations in Blood
研究概览
简要总结
The investigators aimed to investigate the possible differences in metal ion concentrations in patients following one of two types of metal-on-metal articulating hip prosthesis regarding chromium and cobalt concentration, radiological findings, patient reported outcome measures and rate of revision at 5-years follow up.
详细描述
The metal-on-metal large-diameter-head (MoM-LDH) hip replacements increased in popularity during the start of the 21st century. Subsequently reports raised concerns regarding adverse reactions due to elevated chromium (Cr) and cobalt (Co) concentrations as well as high rates of other complications and revisions.
This was a single center parallel-group randomized controlled trial. The primary outcome was to compare Cr and Co concentrations at 5-years follow up following MoM-LDH total hip arthroplasty (MoM-LDH-THA) or MoM-LDH hip resurfacing (MoM-LDH-HR).
Secondary outcomes were radiological findings, patient reported outcome measures and revision rate at 5-years follow up.
The study was prematurely terminated in 2012 due to alerts and safety communications from the Danish national regulatory agency regarding early failure rates and high incidence of ARMD in patients with MoM hip implants [13]. At that time the study population consisted of 75 patients out of 200 planned for inclusion.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Both the care provider and patient were blinded until day of surgery. The laboratory analyzing blood metal concentrations were blinded to treatment allocation throughout the study.
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
- •Primary or secondary hip osteoarthritis eligible for hip replacement surgery
- •Able to give informed consent
- •Able to complete follow up consultations
排除标准
- •Earlier or present infection of the hip
- •Severe systemic or metabolic disease leading to weakening of the bone
- •Severe congenital hip dysplasia
- •Osteoporosis and/or renal disease
结局指标
主要结局
Metal Ion Concentrations in Blood
时间窗: at 5 years follow up
Chromium and cobalt concentrations in whole blood
次要结局
- SF-36(at 5 years follow up)
- Number of Patients Undergoing Revision(at 5 years follow up)
- Harris Hip Score(at 5 years follow up)
研究者
Anders Troelsen
MD, PhD, dr.med., Professor
Hvidovre University Hospital