Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR
NCT ID: NCT02385968
Last Updated: 2024-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
5 participants
OBSERVATIONAL
2014-10-31
2016-10-31
Brief Summary
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A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.
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Detailed Description
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The primary outcome, i.e., bacterial growth on a per-patient basis. Bacterial growth shall be detected in minimum 3 out of 5 biopsies for the patient to be scored as positive for bacteria.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 65 years.
* No prior spine surgery.
* No diagnosed dementia.
Exclusion Criteria
* History of alcohol abuse, illicit drug use or drug abuse, or significant mental illness
* Known immune deficiency state (e.g., positive for human immunodeficiency virus) or in treatment with immunosuppressive drugs including high dose steroids or cyclosporine.
* Concurrent infections (infections of skin, urinary tract infection, other skin diseases, e.g. Acne vulgaris).
* Previous epidural instrumentation.
* Uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.
18 Years
65 Years
ALL
No
Sponsors
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Vejle Hospital
OTHER
Spine Centre of Southern Denmark
OTHER
Responsible Party
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Karen Højmark Hansen
Research nurse
Principal Investigators
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Karen H. Hansen
Role: PRINCIPAL_INVESTIGATOR
Sygehus Lillebaelt
Locations
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Middelfart Spinesurgery research department
Middelfart, Region Syddanmark, Denmark
Countries
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Other Identifiers
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S-20140085
Identifier Type: -
Identifier Source: org_study_id
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