NCT03769337|UnknownDMC
New Markers for Diagnosis of Prosthetic Infections
Perimarkers
Identification of New Biological Marker for Diagnosis of Periprosthetic Infections
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Perimarkers
Identification of New Biological Marker for Diagnosis of Periprosthetic Infections
Sponsor study identifier
observational
130
1 country
1
Study Start
September 1, 2018
Actual (reported)Primary Completion
August 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Implant infections are among the most dramatic complications in orthopaedic surgery with heavy impact on life quality and health system. Their diagnosis is still challenging since, till now, none othe proposed markers has shown a sensitivity and a specificity of100%. Therefore, efforts in identification of new markers of infections are required. This study aims to evaluate the applicability of Interleukin (IL)-6, Triggering receptor expressed on myeloid cells (TREM-1), CC chemokine ligand 2 (CCL2), matrix metalloproteinases (MMP-9), osteopontin (OPN), IL-1 receptor antagonist (IL1-RA), IL-6 receptor beta (GP130), C5a, receptor for advanced glycation end products (sRAGE), urokinases and presepsin as serum markers of prosthetic joint infection. At this purpose, serum from 65 patients with infected implant and from 65 with aseptic failure of their prosthesis will be collected before surgery and after 2 and 7 days from revision.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
September 1, 2018
Actual (reported)December 6, 2018
Actual (reported)December 7, 2018
Actual (reported)August 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Statistically significant differences in serum concentrations of IL-6 between infected and not-infected patients
Serum concentrations of IL-6 will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Statistically significant differences in serum concentrations of TREM-1 between infected and not-infected patients
Serum concentrations of TREM-1 in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Statistically significant differences in serum concentrations of CCL-2 between infected and not-infected patients
Serum concentrations of CCL2 in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Statistically significant differences in serum concentrations of MMP-9 between infected and not-infected patients
Serum concentrations of MMP-9 in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Serum biomarkers in patients with diagnosis of prosthetic joint infection
Serum biomarkers in patients with implant failure not caused by infection
Measurement of Serum concentrations of IL-6, TREM-1, CCL2, MMP-9, OPN, IL-1RA, GP-130, C5a, sRAGE, urokinase and presepsin before revision surgery and after 2 and 7 days after surgery
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with failure of prosthetic implant
IRCCS Istituto Ortopedico Galeazzi
Milan, MI, 20161, Italy
Serum
Elena De Vecchi, MSc
IRCCS Istituto Ortopedico Galeazzi
First Submitted
December 6, 2018
First Posted
December 7, 2018
Study Start
September 1, 2018
Actual (reported)Primary Completion
August 31, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Statistically significant differences in serum concentrations of OPN between infected and not-infected patients
Serum concentrations of OPN in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Statistically significant differences in serum concentrations of IL-1RA, between infected and not-infected patients
Serum concentrations of IL-1RA in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Statistically significant differences in serum concentrations of GP-130 between infected and not-infected patients
Serum concentrations of GP-130 in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Statistically significant differences in serum concentrations of C5a between infected and not-infected patients
Serum concentrations of C5a in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Statistically significant differences in serum concentrations of sRAGE between infected and not-infected patients
Serum concentrations of sRAGE in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Statistically significant differences in serum concentrations of urokinase between infected and not-infected patients
Serum concentrations of urokinase in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Statistically significant differences in serum concentrations of presepsin between infected and not-infected patients
Serum concentrations of presepsin in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.
within 1 year after collection of all samples
Contact the study team to confirm eligibility.
Study Completion
September 30, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 24, 2018
Record last verified: 2018-11
De-identified participants data for all primary outcome measures will be made available
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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