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Alpha Defensin and 16S rRNA Gene in Diagnosis of PJI

NCT03714165 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 90

Last updated 2018-10-22

No results posted yet for this study

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

Conditions

  • Prosthetic Joint Infection

Interventions

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Osama Bakr Sedek, MD · Assuit Univeristy

  • Dalia Tarik Kamal, MD · Assuit Univeristy

  • Amal Mohammed Hosney, MD · Assuit Univeristy

  • Ayat Bakhet Mostafa, Dr · Assuit Univeristy

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2020-01-01
Completion
2020-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03714165 on ClinicalTrials.gov