Comparison of Directed Versus Undirected Synovial Biopsy in Culture-negative Periprosthetic Joint Infections (With Preoperative Smears From the Skin) of the Knee and Evaluation of Outcome After Revision Joint Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Correlation of microbiological and histological results of undirected and directed synovial biopsies
研究概览
简要总结
The purpose of this study is to determine whether an undirected synovial biopsy technique has the same accuracy in detecting periprosthetic joint infection in the knee as an arthroscopic assisted directed synovial biopsy technique.
详细描述
Successful treatment of an infected joint arthroplasty depends on correctly identifying the responsible pathogens. The value of a preoperative biopsy remains controversial. We compared the sensitivity and specificity of two techniques of synovial biopsy of knee joint arthroplasties suspicious for infection and asked whether the results correlate with intraoperative findings at revision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Chronic painful knee prosthesis planned for synovial biopsy to detect infection
- •Culture-negative joint aspiration
排除标准
- •Co-morbidities: Tumour disease, immune suppression
结局指标
主要结局
Correlation of microbiological and histological results of undirected and directed synovial biopsies
时间窗: within the first 14 days after surgery
5 microbiological samples and 1 histological sample are taken form the knee undirected via an antero-lateral approach. Afterwards the same sample numbers are taken under arthroscopic view. Correlation of results between those two methods are investigated. If infection is detected two-stage exchange of prosthesis is performed. At this surgery samples from synovia and the implant-bone interface are again taken and again investigated for correlation.
次要结局
- Correlation of microbiological results from synovial biopsy with intraoperative findings at revision(within the first 14 days after surgery)
研究者
Harrasser
Dr.
Technical University of Munich