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New Markers for Diagnosis of Prosthetic Infections (Perimarkers)

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ClinicalTrials.gov Identifier: NCT03769337
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Brief Summary:

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.


Condition or disease Intervention/treatment
Prosthetic Joint Infections Diagnostic Test: serum biomarkers

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Identification of New Biological Marker for Diagnosis of Periprosthetic Infections
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Infected
Serum biomarkers in patients with diagnosis of prosthetic joint infection
Diagnostic Test: serum biomarkers
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

Not Infected
Serum biomarkers in patients with implant failure not caused by infection
Diagnostic Test: serum biomarkers
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




Primary Outcome Measures :
  1. Statistically significant differences in serum concentrations of IL-6 between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    Serum concentrations of IL-6 will be compared before surgery and at 2 and 7 days after implant revision.

  2. Statistically significant differences in serum concentrations of TREM-1 between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    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.

  3. Statistically significant differences in serum concentrations of CCL-2 between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    Serum concentrations of CCL2 in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.

  4. Statistically significant differences in serum concentrations of MMP-9 between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    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.

  5. Statistically significant differences in serum concentrations of OPN between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    Serum concentrations of OPN in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.

  6. Statistically significant differences in serum concentrations of IL-1RA, between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    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.

  7. Statistically significant differences in serum concentrations of GP-130 between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    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.

  8. Statistically significant differences in serum concentrations of C5a between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    Serum concentrations of C5a in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.

  9. Statistically significant differences in serum concentrations of sRAGE between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    Serum concentrations of sRAGE in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.

  10. Statistically significant differences in serum concentrations of urokinase between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    Serum concentrations of urokinase in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.

  11. Statistically significant differences in serum concentrations of presepsin between infected and not-infected patients [ Time Frame: within 1 year after collection of all samples ]
    Serum concentrations of presepsin in infected and not-infected patients will be compared before surgery and at 2 and 7 days after implant revision.


Biospecimen Retention:   Samples Without DNA
Serum


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with failure of prosthetic implant
Criteria

Inclusion Criteria:

  • Patients with diagnosis of septic or aseptic failure of prosthetic implant
  • Informed consent signed

Exclusion Criteria:

  • Patients undergoing revision surgery for failure not due to the above mentioned causes
  • Known auto immune diseases or other conditions which might alter inflammatory response

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769337


Contacts
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Contact: Elena Cittera, MSc 00390266214057 elena.cittera@grupposandonato.it

Locations
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Italy
IRCCS Istituto Ortopedico Galeazzi Recruiting
Milan, MI, Italy, 20161
Contact: Elena Cittera, MSc    00390266214057    elena.cittera@grupposandonato.it   
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
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Principal Investigator: Elena De Vecchi, MSc IRCCS Istituto Ortopedico Galeazzi

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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03769337     History of Changes
Other Study ID Numbers: Perimarkers
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified participants data for all primary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Data will be made available within 1 year after completion of the study
Access Criteria: Data access request will be sent to the facility

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Istituto Ortopedico Galeazzi:
serum markers of infections

Additional relevant MeSH terms:
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Infection
Communicable Diseases