Identification of Infections in Hip Arthroplasty Loosening.

NCT04773054 | Completed DMC

• 1 other identifier: TAS-ASEPTIC
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hip arthroplasty; Infection; Microbiota; Next Generation Sequencing

Outcome Measures

Primary Outcomes (3)

• Identification of microorganisms by microbiological cultures (number of patients with positive microbiological culture).

  Tissue samples will be sent for microbiological cultures and treated for the isolation of aerobic and anaerobic pathogens. The existence of two positive cultures will be considered to be diagnostic for periprosthetic infection; a single positive culture may occur from a contaminating organism and will be considered in conjunction with other markers of infection, including histological features.

  Within two week of admission

• Number of patients with histological features of periprosthetic infection

  The presence of a periprosthetic infection will be established according to the number of polymorphonuclear cells (PMN) counted in ten high-power fields (HPF) (400 × magnification, field diameter 0.54 mm)- Uninfected: 0-5 PMNs in 10 HPFs; borderline, but probably not infected: 6-10 PMNs for 10 HPF; borderline, but probably infected: \>10 PMNs for 10 HPFs (but not \> 5 PMNs in a single HPF); infected \> 5 for HPF.

  Within two week of admission

• Identification of microorganisms by next-generation sequencing (NGS) (number of patients with positive NGS).

  The NGS will be employed to characterize the overall microbiome profile in tissue samples, and bioinformatics used to determine the taxonomic and phylogenetic affiliation, alpha-diversity (ecological diversity of a single sample according to the number of different taxa and their relative abundances), and beta-diversity (differences in microbial community composition between samples).

  Through study completion, an average of 6 months.

Secondary Outcomes (5)

• Characterization of taxonomic and phylogenetic affiliation of gut microbiota

  Through study completion, an average of 6 months.

• Characterization of alpha-diversity and beta-diversity of gut microbiota

  Through study completion, an average of 6 months.

• Characterization of taxonomic and phylogenetic affiliation of oral microbiota

  Through study completion, an average of 6 months.

• Characterization of alpha-diversity and beta-diversity of oral microbiota

  Through study completion, an average of 6 months.

• Number of patients with inflammatory cellular reactivity related to bacterial products.

  Through study completion, an average of 6 months.

Interventions

Microbiological analysis of periprosthetic tissue DIAGNOSTIC_TEST

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.

Histological analysis of periprosthetic tissue DIAGNOSTIC_TEST

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.

Characterization of tissue microbiota OTHER

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.

Characterization of gut microbiota OTHER

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

Characterization of oral microbiota OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients admitted at the 1st Orthopaedic and Traumatology Unit of the Istituto Ortopedico Rizzoli (Bologna, Italy).

You may qualify if:

• Hip arthroplasty revision for aseptic loosening, diagnosis determined as probable according to the following criteria:
• pain and/or functional impairment;
• radiographic signs of osteolysis following wear of the implant components, or cortical reaction, or periprosthetic bone resorption;
• negative evaluation by the infectious disease specialist.

You may not qualify if:

• presence of a sinus tract communicating with the arthroplasty;
• bacteria isolation from aspirates or blood cultures performed preoperatively;
• serum C-reactive protein higher than 10 mg/L;
• recurrent implant dislocations;
• prosthetic fracture;
• medical history for septic arthritis, osteomyelitis;
• infections in anatomic areas other than hip;
• antibiotic therapy in the 15 days prior to surgery (with the exception of preoperative antibiotic prophylaxis);
• chronic treatment with immunosuppressive drugs;
• medical contraindications for executing sample collection.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (3)

• Goswami K, Parvizi J. Culture-negative periprosthetic joint infection: is there a diagnostic role for next-generation sequencing? Expert Rev Mol Diagn. 2020 Mar;20(3):269-272. doi: 10.1080/14737159.2020.1707080. Epub 2019 Dec 24. No abstract available.

  PMID: 31858850 BACKGROUND

• Tarabichi M, Shohat N, Goswami K, Alvand A, Silibovsky R, Belden K, Parvizi J. Diagnosis of Periprosthetic Joint Infection: The Potential of Next-Generation Sequencing. J Bone Joint Surg Am. 2018 Jan 17;100(2):147-154. doi: 10.2106/JBJS.17.00434.

  PMID: 29342065 BACKGROUND

• Pajarinen J, Jamsen E, Konttinen YT, Goodman SB. Innate immune reactions in septic and aseptic osteolysis around hip implants. J Long Term Eff Med Implants. 2014;24(4):283-96. doi: 10.1615/jlongtermeffmedimplants.2014010564.

  PMID: 25747031 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

tissue, oral mucosa, stools

MeSH Terms

Conditions

Prosthesis Failure; Infections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicola Baldini

  University of Bologna, Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Director of the Research Innovation & Technology Department

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 26, 2021
• Study Start: February 8, 2022
• Primary Completion: December 11, 2023
• Study Completion: February 15, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

IT (1)