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临床试验/NCT01454271
NCT01454271撤回1 期

Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate

Laboratoire Ceraver-Osteal2 个研究点 分布在 1 个国家开始时间: 2011年10月18日最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

发起方
Laboratoire Ceraver-Osteal
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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