Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Femoral component osseous-integration
研究概览
简要总结
The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to be less than 1% but remains a severe and costly complication, source of morbidity and even mortality. The "biofilm" forms very early after the bacterial contamination of the prosthesis and poses a number of clinical challenges due to his resistance to immune defence mechanisms and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS) is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also proved his biocompatibility and osseous-integration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age less than 75 years old
- •Aetiologies for THA : primary osteoarthritis, inflammatory diseases,Osteonecrosis
排除标准
- •Previous infectious hip arthritis
- •Previous surgeries on the operated hip
- •Revision of THA
研究组 & 干预措施
Total Hip Arthroplasty CERAFIT® grafted
干预措施: Total Hip Arthroplasty Replacement (Procedure)
结局指标
主要结局
Femoral component osseous-integration
时间窗: 1 year after surgery
Scoring system of Engh
次要结局
- Infection rate(1 year after surgery)
- Quality of Life(One, three, six and twelve months after surgery)
