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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
Sponsor:
Information provided by (Responsible Party):
Ayat Bakhet, Assiut University

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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 fluid
    Other Names:
    • CBC
    • CRP
    • ESR
    • Culture and antibiotic sensitivity of synovial fluid


Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will be conducted on 90 informed individuals (according to guidelines of ethical committee of faculty of medicine , Assuit University )
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • Any patient began antibiotic treatment will be excludes from the samples.

Information from the National Library of Medicine

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


Contacts
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Contact: Ayat Bakhet Mostafa, Dr 01003880813 ayabakhet87@yahoo.com

Locations
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Egypt
Ayat Bakhet Mostafa Recruiting
Assuit, Egypt
Contact: Ayat Bakhet Mostafa, Dr    01003880813    ayabakhet87@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
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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

Publications:
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Responsible Party: Ayat Bakhet, Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03714165     History of Changes
Other Study ID Numbers: Diagnosis of PJI
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ayat Bakhet, Assiut University:
Alpha defensin
16S rRNA gene

Additional relevant MeSH terms:
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Infection
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Anti-Bacterial Agents
Defensins
alpha-Defensins
Anti-Infective Agents