A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 4
- 主要终点
- Composite Clinical Success (CCS) Rate as Defined in the Protocol
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 M2a-38™ mm cup compared to the metal on metal articulation using the same cup.
详细描述
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with osteoarthritis and suitable for primary Total Hip Replacement
- •Patients preoperative Harris Hip Score <= 70 points
- •Patients aged over 18 and under 75
- •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
- •Patients preoperative Harris Hip Score > 70 points
- •Previous prosthetic hip surgery
- •Patients with significant co-morbidity - ASA IV - V
- •Dementia and inability to understand and follow instructions
- •Neurological conditions affecting movement
- •Existing metal implant or fixation device
- •Pregnancy
- •Presence of symptomatic arthritis in other lower limb joints
结局指标
主要结局
Composite Clinical Success (CCS) Rate as Defined in the Protocol
时间窗: 2 years post-operatively
CCS is defined as: a. Total Harris Hip Score \> 80 points, and b. No acetabular or femoral revision or removal, and c. No pending acetabular or femoral revision or removal as defined in radiographic evaluation by: i. An acetabular radiographic assessment with all of the following: 1. Migration \< 4 mm, and 2. Change in angle of inclination \< 4o, and 3. Absence of osteolysis, and ii. A femoral radiographic assessment with all of the following: 1. Subsidence \< 5 mm, and 2. Absence of osteolysis. The HHS including a series of questions answered by the patient and physical examinations recorded by a qualified health care professional covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, 0-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70
次要结局
- Oxford Hip Score(pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively)
- Womac Score(pre-operatively, 6 weeks post-operatively, 6 months post-operatively, 1, 2, 3, 4, 5 and 10 years post-operatively)
- Metal Ion Concentrations in Blood(6 months post-operatively, 1, 2, 3 and 5 years post-operatively)
- Survivorship(10 years post-op)