A Study to Assess the Utility of Cell Count and Differential of Aspirated Fluid in the Diagnosis of Native Vertebral Osteomyelitis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-009619
Sponsor Protocol Number: 18-009619
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Talha Riaz, M.B.B.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available