Mineral-Nano-Pathology : Wear of Hip Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- types of particles that cause the most tissue inflammation
研究概览
简要总结
Hip arthroplasty is a treatment widely used in most inflammatory, traumatic and degenerative conditions of this joint. The longevity of implants may be disappointing in some cases, despite the promising results obtained during in vitro simulations. Early loco-regional or systemic dissemination, known since the 1990s, of wear particles from these prosthesis may reduce their life span.
The analysis of the particles in the synovial fluid and in the articular tissues by electron microscopy after digestion or directly by optical microscopy, will improve the knowledge on the mechanisms of wear.
This category 3 study is based on the case-control model and will be conducted in a national reference center (hospital la Croix-Rousse- Lyon). It will include a population of adult patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adult patient,
- •Patient including French,
- •Patient witness: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for a first hip prosthesis
- •Patient test: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for the removal of a hip prosthesis
排除标准
- •Patient protected by law (guardianship, curatorship, safeguard of justice).
- •Pregnant or lactating woman
- •Patient with suspicion of infection on prosthesis
- •Patient opposing his participation in the study
结局指标
主要结局
types of particles that cause the most tissue inflammation
时间窗: day of surgery
Types of wear particles most found in patients whose tissues are classified as inflammatory. The particles can be classified by size, shape, material and type of original prosthesis.
次要结局
未报告次要终点