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Identification of Infections in Hip Arthroplasty Loosening.

NCT04773054 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2024-03-20

No results posted yet for this study

Summary

Recent data showed that the rate of periprosthetic infections in patients undergoing a hip arthroplasty revision for aseptic loosening is higher than what can be ascertained with conventional methods.

The study aims to assess the adequacy of next-generation sequencing of 16s ribosomal ribonucleic acid (rRNA) gene amplicons for identifying occult infections and improving the diagnostic workup. Moreover, additional testing has been planned in order to increase knowledge on the etiopathogenesis of infection.

Conditions

  • Loosening, Prosthesis

Interventions

DIAGNOSTIC_TEST

Microbiological analysis of periprosthetic tissue

Microbiological culture of tissue samples collected intraoperatively from the newly-formed joint capsule, between prosthesis stem and femoral bone, and between the acetabular prosthesis and iliac bone.

DIAGNOSTIC_TEST

Histological analysis of periprosthetic tissue

Histological assessment of cellular reactivity associated with the infection on tissue samples collected intraoperatively from the newly-formed joint capsule, between prosthesis stem and femoral bone, and between the acetabular prosthesis and iliac bone.

OTHER

Characterization of tissue microbiota

Assessment of tissue microbiome composition using the "next-generation sequencing" of DNA extracted from samples collected intraoperatively from the newly-formed joint capsule, between prosthesis stem and femoral bone, and between the acetabular prosthesis and iliac bone.

OTHER

Characterization of gut microbiota

Assessment of gut microbiome composition using the "next-generation sequencing" of DNA extracted from stool samples.

OTHER

Characterization of oral microbiota

Assessment of oral microbiome composition using the "next-generation sequencing" of DNA extracted from a buccal swab obtained by rubbing the mucosa of cheeks, gingivae, and palate.

Sponsors & Collaborators

  • Istituto Ortopedico Rizzoli

    lead OTHER

Principal Investigators

  • Nicola Baldini · University of Bologna, Istituto Ortopedico Rizzoli

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2023-12-11
Completion
2024-02-15

Countries

  • Italy

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 NCT04773054 on ClinicalTrials.gov