Diagnostic Accuracy of Synovial Biopsy for Implant-Related Shoulder Infections
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 118
- 试验地点
- 8
- 主要终点
- Synovial Biopsy (test diagnostic) and Open Biopsy (reference standard)
研究概览
简要总结
The purpose of this study is to determine the efficacy of retrieving tissue samples via an x-ray guided needle that is inserted into the infected tissue in the shoulder. The procedure using the guided needle is called a synovial biopsy versus an open tissue biopsy, which is done at the time of surgery. By doing the synovial biopsy prior to a revision surgery, the investigators hope to avoid more invasive intervention if it is not needed. Some patients may appear to have an infection but once the biopsy is taken and the results are read, there may not be an infection and therefore no need for a revision surgery.
详细描述
The primary research objective is to assess the diagnostic accuracy of percutaneous synovial biopsy for detection of implant-related intra-articular shoulder infections (IISI).
The secondary objectives are to document the frequency of pain associated with shoulder synovial biopsy and to determine the correlation and agreement of several indices of infection as a means of providing preliminary evidence toward a clinical decision rule to rule in or rule out the diagnosis of implant-related intra-articular shoulder infection.
The third objective is to determine the rates of (re)infection, functional outcomes, and quality of life, over a two year follow up period following revision surgery.
The fourth objective is to determine whether an association exists between the biopsy location within the joint and relative yield and positive culture rates.
The fifth objective is to identify, develop, and validate tissue-specific biomarkers for the detection of IISI.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previous shoulder surgery including hemiarthroplasty, total shoulder arthroplasty or reverse total shoulder arthroplasty, or internal fixation for shoulder fractures
- •Suspicion of infection, including acute fever and complaints of pain and/or stiffness post operatively
- •Revision shoulder surgery for patients described in (1)
- •Provide consent
排除标准
- •signs or symptoms of bacteremia or sepsis requiring urgent treatment, which would preclude the possibility of synovial biopsy
- •Unable to speak or read English/French
- •Psychiatric illness that precludes informed consent
结局指标
主要结局
Synovial Biopsy (test diagnostic) and Open Biopsy (reference standard)
时间窗: Pre-operatively.
To assess the diagnostic accuracy of percutaneous synovial biopsy (test procedure) for detection of implant-related intraarticular shoulder infections (IISI), in comparison to direct macroscopic synovial biopsy, from either arthroscopic or open procedures (the reference standard). To address the primary objective, standard diagnostic accuracy statistics (sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio) will be derived, comparing lab results from percutaneous synovial biopsy specimen collection to those of the reference standard test (open/arthroscopic).
次要结局
- Reported Pain(24-hours after biopsy.)