A Multicentre Prospective Randomised Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic on Metal and Metal on Metal Large Diameter Femoral Heads, as Used in Cementless Primary Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Metal ion concentration in blood and urine
研究概览
简要总结
The aim of this study is to demonstrate the non-inferiority of the ceramic-on-metal articulation using large diameter bearings (38mm to 60mm) compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate at 2 years postoperatively (delta = 10% minimum clinically significant difference in rates).
详细描述
This multicentre randomised controlled trial will compare the clinical outcome of the ceramic-on-metal articulation against a metal-on-metal articulation using the same Recap Acetabular cup.
The metal ion release will be evaluated at predetermined postoperative intervals during the first 36 months. A trial will be conducted as a clinical trial in accordance with the Medical Devices Directive 93/42/EEC (2002).
A total of 150 patients have to be recruited from the South African centre (2 groups)
The initial study assessment period will be 48 months; 24 months recruitment and 24 months follow-up. The follow-up reviews will be at 6 weeks, 6 months, 1 year, 2 years and 3 years. A 5 year and 10 year clinical review will also be carried out with all patients.
An assessment of incidences of adverse events and metal ion release concentrations will be made when all patients are at 6 months postoperatively.
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
- Single (Participant)
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 total hip replacement
- •Patient with degenerative joint disease (inflammatory or non-inflammatory) or any of the composite diagnoses of osteoarthritis,avascular necrosis, legg perthes, rheumatoid arthritis, diastrophic variant, fracture of the pelvis, fused hip, slipped capital epiphysis, subcapital fractures, traumatic arthritis
- •Patients preoperative Harris hip score < 80 points
- •Patients with limited co-morbidity - ASA I - III
- •Patients with normal urea and electrolyte levels and creatinine levels
- •Patients must be able to understand instructions and be willing to return for follow-up
- •Patients willing to provide blood and urine samples for metal ion analysis at follow-up
排除标准
- •Patient preoperative Harris hip score > 80 points
- •Pre-existing metal implants
- •Patients with significant co-morbidity - ASSA IV - V
- •Dementia and inability to understand and follow instructions
- •Neurological conditions affecting movement
- •Women younger than 45 years old
- •Presence of symptomatic arthritis in other lower limb joints
- •Patients requiring smaller than 38mm and larger than 60mm diameter femoral heads
- •Patients taking NSAIDs and / all drugs that will affect bone metabolism
结局指标
主要结局
Metal ion concentration in blood and urine
时间窗: 2 years post operatively
Metal ion concentration will be determined from patients blood and urine at prescribed intervals
次要结局
- Composite Clinical Score (CCS) rate at 2 years post operative(2 years post operatively)