Alpha Defensin and 16S rRNA Gene in Diagnosis of PJI

NCT03714165 | Unknown

• 1 other identifier: Diagnosis of PJI
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Prosthetic Joint Infection

Keywords

Alpha defensin; 16S rRNA gene

Outcome Measures

Primary Outcomes (2)

• Diagnostic value of Alpha defensin in diagnosis of Prosthetic joint infection

  value of measuring Alpha defensin by enzyme linked immunosorbent assay (ELISA) in diagnosis of Prosthetic joint infection as a rapid bio marker

  2 days

• Diagnostic value of 16S rRNA gene in diagnosis of Prosthetic joint infection

  value of measuring 16S rRNA gene by conventional PCR in diagnosis of Prosthetic joint infection as more accurate test

  2 days

Interventions

Alpha defensin and 16SrRNA gene DIAGNOSTIC_TEST

Alpha defensin 16S rRNA gene CBC: Complete blood count CRP: C reactive protein ESR: Erythrocyte sedimentation rate Culture and antibiotic sensitivity of synovial fluid

Also known as: CBC, CRP, ESR, Culture and antibiotic sensitivity of synovial fluid

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 )

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ayat Bakhet Mostafa

Asyut, Egypt

RECRUITING

Related Publications (2)

• Slullitel PA, Onativia JI, Buttaro MA, Sanchez ML, Comba F, Zanotti G, Piccaluga F. State-of-the-art diagnosis and surgical treatment of acute peri-prosthetic joint infection following primary total hip arthroplasty. EFORT Open Rev. 2018 Jul 17;3(7):434-441. doi: 10.1302/2058-5241.3.170032. eCollection 2018 Jul.

  PMID: 30233819 BACKGROUND

• Dudareva M, Barrett L, Figtree M, Scarborough M, Watanabe M, Newnham R, Wallis R, Oakley S, Kendrick B, Stubbs D, McNally MA, Bejon P, Atkins BA, Taylor A, Brent AJ. Sonication versus Tissue Sampling for Diagnosis of Prosthetic Joint and Other Orthopedic Device-Related Infections. J Clin Microbiol. 2018 Nov 27;56(12):e00688-18. doi: 10.1128/JCM.00688-18. Print 2018 Dec.

  PMID: 30209185 BACKGROUND

Study Officials

• Osama Bakr Sedek, MD

  Assuit Univeristy

  PRINCIPAL INVESTIGATOR

• Dalia Tarik Kamal, MD

  Assuit Univeristy

  STUDY CHAIR

• Amal Mohammed Hosney, MD

  Assuit Univeristy

  STUDY CHAIR

• Ayat Bakhet Mostafa, Dr

  Assuit Univeristy

  STUDY DIRECTOR

Central Study Contacts

Ayat Bakhet Mostafa, Dr

CONTACT

01003880813; ayabakhet87@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 22, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 22, 2018

Record last verified: 2018-10

Locations

EG (1)