NCT04773054|CompletedDMC
Identification of Infections in Hip Arthroplasty Loosening.
Application of Advanced High-sensitivity Technologies for Identifying Infections in Patients With Aseptic Loosening of Hip Arthroplasty.
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Application of Advanced High-sensitivity Technologies for Identifying Infections in Patients With Aseptic Loosening of Hip Arthroplasty.
Sponsor study identifier
observational
11
1 country
1
Study Start
February 8, 2022
Actual (reported)Primary Completion
December 11, 2023
Actual (reported)Study Completion
February 15, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 15, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 16, 2021
Actual (reported)February 26, 2021
Actual (reported)February 8, 2022
Actual (reported)December 11, 2023
Actual (reported)February 15, 2024
Actual (reported)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.
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.
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 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.
Hospitalized patients admitted at the 1st Orthopaedic and Traumatology Unit of the Istituto Ortopedico Rizzoli (Bologna, Italy).
Istituto Ortopedico Rizzoli
Bologna, 40136, Italy
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.
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.
tissue, oral mucosa, stools
Nicola Baldini
University of Bologna, Istituto Ortopedico Rizzoli
11 participants (actual enrollment reported by the registry).
First Submitted
February 16, 2021
First Posted
February 26, 2021
Study Start
February 8, 2022
Actual (reported)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.
Assessment of gut microbiome composition using the "next-generation sequencing" of DNA extracted from stool samples.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
December 11, 2023
Actual (reported)Study Completion
February 15, 2024
Actual (reported)Last Updated
March 20, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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