NCT03769337

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

December 24, 2018

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

December 6, 2018

Last Update Submit

December 20, 2018

Conditions

Prosthetic Joint Infections

Keywords

serum markers of infections

Outcome Measures

Primary Outcomes (11)

  • 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

  • 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

Study Arms (2)

Infected

Serum biomarkers in patients with diagnosis of prosthetic joint infection

Diagnostic Test: serum biomarkers

Not Infected

Serum biomarkers in patients with implant failure not caused by infection

Diagnostic Test: serum biomarkers

Interventions

serum biomarkersDIAGNOSTIC_TEST

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

InfectedNot Infected

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with failure of prosthetic implant

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, MI, 20161, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Study Officials

  • Elena De Vecchi, MSc

    IRCCS Istituto Ortopedico Galeazzi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Cittera, MSc

CONTACT

00390266214057elena.cittera@grupposandonato.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2018

First Posted

December 7, 2018

Study Start

September 1, 2018

Primary Completion

August 31, 2020

Study Completion

September 30, 2020

Last Updated

December 24, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

De-identified participants data for all primary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, 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

Locations

IT(1)