Utility of Alpha Defensin and 16S rRNA Gene in Diagnosis of Prosthetic Joint Infection
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Diagnostic value of Alpha defensin in diagnosis of Prosthetic joint infection
研究概览
简要总结
Total joint replacement is considered one of the most successful surgical procedures in the field of orthopedics. Despite this achievement, prosthetic joint infections is still considered a severe complication often leading to catastrophic results and requiring repeated and extensive treatment.
The incidence of PJI (a prosthetic joint infection) varies depending on the joint involved; the rate of arthroplasties becoming infected is as follows: 1.7% of primary and 3.2%of non-primary hip arthroplasties.
The accurate diagnosis of prosthetic joint infection often involves the combination of multiple factors including symptoms, signs, synovial fluid cell count, serum inflammatory markers, and culture.
The sensitivity of synovial fluid culture is only 85%, so a negative culture does not rule out infection. However, the specificity of synovial fluid culture is approximately 95%, and positive cultures often imply the presence of prosthetic joint infection.
The synovial fluid alpha-defensin test is an immunoassay that was specifically developed to aid in the diagnosis of prosthetic joint infection .
The sensitivity and the specificity of the alpha-defensin immunoassay test have been reported to be above 96%.
Molecular diagnostic tests using polymerase chain reaction (PCR) are emerging as a tool for the diagnosis of infections and noninfectious conditions. The application of PCR techniques with primers derived from the highly conserved regions of the bacterial 16S rRNA gene has been useful in the detection of bacterial organisms.
Use of broad-range 16S rRNA gene PCR as a tool for identification of bacteria is possible because the 16S rRNA gene is present in all bacteria .
Aim of the work:
.Determine sensitivity and specificity of alpha defensing and 16S rRNA gene in diagnosis of prosthetic joint infection.
- Detection of antibiotic sensitivity for different organisms isolated from synovial fluid
详细描述
Total joint replacement is considered one of the most successful surgical procedures in the field of orthopedics, alleviating pain and limitation of movement due to degenerative or traumatic joint damage. Despite this achievement, prosthetic joint infections is still considered a severe complication often leading to catastrophic results and requiring repeated and extensive treatment .
Infection is a major problem in orthopedics leading to implant failure. It is a challenging task to treat orthopedic implant infections that may lead to implant replacement and, in severe cases, may result in amputation and mortality Sources of infectious bacteria include the environment of the operating room, surgical equipment, clothing worn by medical and paramedical staff, resident bacteria on the patient's skin and bacteria already residing in the patient's body Implant-associated infections are the result of bacteria adhesion to an implant surface and subsequent biofilm formation at the implantation site .
Staphylococci account for more than 50% of total prosthetic joint infections. Approximately 20% may be polymicrobial, 15% caused by gram-negative, and about 10% are culture negative .
The incidence of PJI (a prosthetic joint infection) varies depending on the joint involved; the rate of arthroplasties becoming infected is as follows: 1.7% of primary and3.2%of non-primary hip arthroplasties .
A correct and early appropriate therapy if correct and timely microbiological diagnosis of infections is done within 4 weeks, it could be possible to follow a conservative approach on the prosthesis, since microorganisms are not yet organized in biofilms. A delayed diagnosis (>4 weeks) of early and late infections involves the necessity of prosthesis removal due to the production of a structured and mature microbial biofilm . The definition of PJI was recently revised by the International Consensus Group on Periprosthetic Joint Infection
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study will include all patient with prosthetic joint suspected to be infected through clinical manifestation (fever, pain, fistula redness, swelling ,hotness and loss of function) associated with radiological evidence.
排除标准
- •Any patient began antibiotic treatment will be excludes from the samples.
结局指标
主要结局
Diagnostic value of Alpha defensin in diagnosis of Prosthetic joint infection
时间窗: 2 days
value of measuring Alpha defensin by enzyme linked immunosorbent assay (ELISA) in diagnosis of Prosthetic joint infection as a rapid bio marker
Diagnostic value of 16S rRNA gene in diagnosis of Prosthetic joint infection
时间窗: 2 days
value of measuring 16S rRNA gene by conventional PCR in diagnosis of Prosthetic joint infection as more accurate test
次要结局
未报告次要终点