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Cytokine Profiles and suPAR in Spondylodiscitis

NCT02554227 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36

Last updated 2019-08-13

No results posted yet for this study

Summary

Spondylodiscitis is an infectious disease of the intervertebral discs and adjacent vertebral bodies, which often has a protracted progression. Diagnosis is frequently delayed because of the unspecific pathology and a lack of specific infection markers. However, an early diagnosis is fundamental to prevent long periods with symptoms including extensive back pain and progressive and destructive changes of the spine.

Cytokines can be helpful to extend the knowledge about diverse biological processes. Furthermore, they are a promising category of biomarkers that are already present in the early phases of developing diseases. Currently, little is known about the participation of cytokines in Spondylodiscitis. The aim of this study is to establish a non-invasive method to improve the diagnosis of spondylodiscitis. Therefore, blood and tissue samples will be analyzed at different time points for the concentration of specific cytokines to select potential marker cytokines via a Multiplex Assay and suPAR (soluble urokinase-type plasminogen activator receptor) via ELISA. After successful identification of the biomarkers cytokines and suPAR, verification of the results will be done by expression analysis of cytokine-producing cells.

The potential of such a diagnostic method lies in reducing medical costs and preventing extensive pain and structural changes of the spine.

Experimental research will be performed with the approval of the ethic committee of the medical faculty of the University of Cologne.

Conditions

  • Spondylodiscitis

Interventions

OTHER

Cytokine Profile and suPAR

Routine blood collection will be carried out directly before surgery and also during the stationary hospitalization on day 4 and day 10. Additional blood collection will be done after 6 weeks and 3 months during the follow-up.

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Jan Siewe, Dr. med. · University Hospital, Department of Orthopaedic Surgery and Traumatology,

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-06-30
Completion
2017-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554227 on ClinicalTrials.gov