A Study to Assess the Utility of Cell Count and Differential of Aspirated Fluid in the Diagnosis of Native Vertebral Osteomyelitis

Overview

About this study

The purpose of this study is to assess the utility of cell count and differential from aspirated fluid obtained via CT guided needle aspiration biopsy of vertebral bone and intervertebral disc space in the diagnosis of native vertebral osteomyelitis (NVO).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subjects ages > or =18 years old.
  • Subjects with suspected native vertebral osteomyelitis (NVO) and undergoing CT guided aspiration for a clinical indication will be approached and enrolled in the study.
  • Definition of native vertebral osteomyelitis (NVO) - as per IDSA’s vertebral osteomyelitis guidelines, these criteria will include patients with all of the following clinical features:
    • Back pain;
    • Elevated inflammatory markers (CRP, ESR);
    • MRI findings consistent with NVO;
    • A positive vertebral aspirate or a positive blood culture of an organism that is deemed not a contaminant.

Exclusion Criteria: 

  • Those subjects not meeting the above mentioned criteria will be excluded.
  • The study will not include pregnant women or vulnerable populations such as prisoners.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Elie Berbari, M.D.

Open for enrollment

Contact information:

Talha Riaz M.B.B.S.

Riaz.Talha@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20450959

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