A Prospective Randomized Clinical Trial Comparing Ion Levels and Clinical Outcomes of the CONSERVE® A-Class Total Hip System With BFH® Technology to Metal on Polyethylene Total Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Metal ion levels
研究概览
简要总结
The main purpose of this prospective randomized controlled trial is to compare the concentrations of metal ions in the blood and urine of patients receiving implants that are identical except for the acetabular component: one is a monoblock and all cobalt chrome, and the other is modular with a titanium acetabular shell with a polyethylene insert.
详细描述
The primary aim of this study is to demonstrate that blood ion levels (cobalt and chromium) are lower at one year in patients who receive a metal on polyethylene total hip as compared to CONSERVE® A-Class Total Hip with BFH® technology. Secondary aims include the gathering of clinical data regarding survival and dislocation rates at two years post surgery, as well as the assessment of pain, physical function, radiographic and clinical outcome at the two year interval.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals undergoing unilateral total hip replacement.
- •Patients 50 to 70 years of age.
排除标准
- •Patients who have previously undergone any type of joint replacement.
- •Patients with evidence of active infection.
- •Patients with a documented allergy to cobalt chromium molybdenum.
结局指标
主要结局
Metal ion levels
时间窗: 24 months
To compare the metal ion levels between the advanced metal system and the traditional metal on polyethylene total hip replacement system.
次要结局
- Dislocation Rate(24 months)
- Complications(24 months)
- Change in Harris Hip Score(24 months)
- Change in UCLA Questionnaire(24 months)
- Change in WOMAC Questionnaire(24 months)
- Change in RAND-36 Health Survey(24 months)