Detection of Biomarkers for Prosthetic Infection Type - (DEBIT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Bacterial abundance- comparison between patients
研究概览
简要总结
Prosthetic joint infection (PJI) is a significant cause of failure in hip and knee arthroplasty and is often difficult to diagnose using current methods. This study aims to identify novel biomarkers for early and accurate diagnosis of PJI using nanopore sequencing technology (Oxford Nanopore Technologies). By analysing microbial profiles and host immune responses in samples from patients undergoing revision surgery, the study will compare infected and non-infected cases. Biomarkers will be investigated in periprosthetic tissue as well as less invasive sample types, including synovial fluid and blood, with the goal of improving early diagnosis and guiding future treatment strategies.
详细描述
Prosthetic joint infection (PJI) represents one of the most common reasons for failure among hip and knee arthroplasty, with an incidence of around 1-2%. Diagnosing infection can be challenging, as loosening of the implant cement (osteolysis), damage, and metal reactions can be impossible to differentiate without invasive procedures. Given the significant costs to the NHS for corrective revision surgery, the added suffering and risks to patients from surgery, and the risk of enhancing antimicrobial resistance through the use of broad-spectrum antibiotics, a predictive test for early diagnosis of infection is required. In this study, we will use nanopore sequencing platforms from Oxford Nanopore Technologies (ONT) to identify potential novel biomarkers for PJI in samples collected from patients undergoing revision surgery. This study will explore the microbes present, along with the host's immunological response, to identify potential novel biomarkers in infected samples compared to those revised for other reasons. The investigators will test for detection of these biomarkers in tissue surrounding the implant, as well as in less invasive sample types (synovial fluid and blood). These will provide novel biomarkers for diagnosis and early treatment of PJI for the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Male or Female, aged 18 years or above.
- •Due to undergo prosthetic revision surgery for any reason identified by the clinical team.
- •Participant is willing and able to give informed consent for participation in the study.
- •Pre-operative blood samples and at least 5 substantial peri-prosthetic tissue samples of a suitable size to be distributed between labs as outlined were successfully collected (note that it may not be possible to collect synovial fluid in all cases).
排除标准
- •The participant has previously undergone any kind of revision surgery for their hip implant.
- •The participant has received any antibiotic treatment within the previous two weeks (excluding antibiotics at induction).
- •Participant lacking capacity to give informed consent.
- •Any other clinical reason the participant should not be included in the study- at the discretion of the clinical team.
研究组 & 干预措施
Prosthetic joint Replacement
Using nanopore sequencing platforms from Oxford Nanopore Technologies (ONT) to identify potential novel biomarkers for PJI in samples collected from patients undergoing revision surgery
干预措施: Prosthetic joint replacement (Procedure)
结局指标
主要结局
Bacterial abundance- comparison between patients
时间窗: through study completion, an average of 1 year
Bacterial abundance in infected biofilms compared to non-infected biofilms on hip arthroplasty prostheses.
Gene expression levels
时间窗: through study completion, an average of 1 year
Gene expression levels in patients with PJI compared to those undergoing revision surgery for other reasons (e.g. aseptic loosening (osteolysis), periprosthetic fracture, dislocation, etc.).
次要结局
- Bacterial abundance in blood and synovial samples(through study completion, an average of 1 year)
- Gene expression in blood and synovial samples(through study completion, an average of 1 year)