The Use of Silver Doped Calcium Phosphate Based Ceramic Coated Orthopedic Implants for Preventing Implant Related Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of pin site with positive culture resuls
研究概览
简要总结
In this study, CE (European Conformity) marked, domestic manufactured standard orthopedic implants will be used after silver HA coating with electrospray method in 30 patients requiring hip joint prostheses, intramedullary nails or external fixator in 30 patients to antimicrobial effectiveness. These patients will be tasted for liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes,
详细描述
In this study, considering the differences in bone contact surface area and interactions; hip joint prostheses, intramedullary nails and external fixator implants to be used in 30 patients . CE (European Conformity) marked, domestic manufactured standard orthopedic implants will be used in patients after silver HA coating with electrospray method. These patients will be tasted for the evaluation of liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes, and will be monitored for at least 12 months. The performance of coating to be applied and any unwanted side effects in normal conditions of use will be evaluated..
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18-65
- •Patients without heart, lung, renal or hepatic insufficiency
- •Patients without epilepsy, cerebrovascular attack or ischaemia
- •Patients without antibiotic allergy
- •Patients who have low immune defense mechanisms such as malignancy, diabetes mellitus, polytrauma, and open fracture
- •Patients using oral or parenteral corticosteroids, methotrexate, cyclosporine or other immunosuppressive drugs - -
排除标准
- •Pregnant women
- •Patients with another silver implant in their body, such as a silver-coated stent
- •Patients with known allergy or hypersensitivity to silver
- •Patients with too many antibiotics due to recurrent infections
结局指标
主要结局
Number of pin site with positive culture resuls
时间窗: 12 months
incidence of pin tract infection
次要结局
- Number of patient with elevated BUN levels(12 months)
- Number of patient with elevated blood silver(12 months)
- Number of patient with elevated level of serum ALT levels(12 months)
研究者
NUSRET KOSE
Professor of Orhopedics and Traumatology
Eskisehir Osmangazi University