Comparative Study of the Wear of Uncemented Acetabular Conventional Polyethylene and X3 in Total Hip Replacement, for Stereo-radiographic Analysis
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Penetration of the femoral head in the polyethylene measure in millimeters
研究概览
简要总结
Total hip arthroplasty (THA) is one of the most effective medical procedures. Except for the few early complications (acute infections and dislocations), the patient made a PTH can be assured of a significant improvement in its function and its short-term quality of life. However, clinical studies and records have shown that the lifetime of these implants was limited. The main cause of failure is the "aseptic loosening" influenced by many factors, foremost of which is due to periprosthetic osteolysis debris. This is a major concern for orthopedic surgeons loosening leads, in most cases, the recovery, the importance of osteolysis is a major cause of difficulties and poorer results.
The main objective of the study is to compare, 2 years after the intervention, the penetration of the femoral head in the polyethylene and X3 in the acetabulum in N2VAC® conventional polyethylene.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patient (18-70 years) with hip disease necessitating the establishment of a total hip replacement
排除标准
- •Patient aged 71 or more
- •Pregnant woman or wishing to be for the duration of the study
- •Resumption of total hip replacement, or cephalic prosthesis cups
- •Primary or secondary malignant neoplasm of the hip
- •Protected adult patient
结局指标
主要结局
Penetration of the femoral head in the polyethylene measure in millimeters
时间窗: change over baseline and 2 years
The median head penetration in millimeters
次要结局
未报告次要终点