Alpha Defensin and 16S rRNA Gene in Diagnosis of PJI
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|ClinicalTrials.gov Identifier: NCT03714165|
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : October 22, 2018
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
|Condition or disease||Intervention/treatment|
|Prosthetic Joint Infection||Diagnostic Test: Alpha defensin and 16SrRNA gene|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||90 participants|
|Official Title:||Utility of Alpha Defensin and 16S rRNA Gene in Diagnosis of Prosthetic Joint Infection|
|Estimated Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
- Diagnostic Test: Alpha defensin and 16SrRNA gene
Alpha defensin 16S rRNA gene CBC: Complete blood count CRP: C reactive protein ESR: Erythrocyte sedimentation rate Culture and antibiotic sensitivity of synovial fluidOther Names:
- Culture and antibiotic sensitivity of synovial fluid
- Diagnostic value of Alpha defensin in diagnosis of Prosthetic joint infection [ Time Frame: 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 [ Time Frame: 2 days ]value of measuring 16S rRNA gene by conventional PCR in diagnosis of Prosthetic joint infection as more accurate test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03714165
|Contact: Ayat Bakhet Mostafa, Dremail@example.com|
|Ayat Bakhet Mostafa||Recruiting|
|Contact: Ayat Bakhet Mostafa, Dr 01003880813 firstname.lastname@example.org|
|Principal Investigator:||Osama Bakr Sedek, MD||Assuit Univeristy|
|Study Chair:||Dalia Tarik Kamal, MD||Assuit Univeristy|
|Study Chair:||Amal Mohammed Hosney, MD||Assuit Univeristy|
|Study Director:||Ayat Bakhet Mostafa, Dr||Assuit Univeristy|