Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
16 December 2017 |
Main ID: |
NCT02385968 |
Date of registration:
|
04/03/2015 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR
|
Scientific title:
|
Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR |
Date of first enrolment:
|
October 2014 |
Target sample size:
|
5 |
Recruitment status: |
Terminated |
URL:
|
https://clinicaltrials.gov/show/NCT02385968 |
Study type:
|
Observational |
Study design:
|
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Denmark
| | | | | | | |
Contacts
|
Name:
|
Karen H. Hansen |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Sygehus Lillebaelt |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- MRI-confirmed lumbar disc herniation.
- Age between 18 and 65 years.
- No prior spine surgery.
- No diagnosed dementia.
Exclusion Criteria:
- Antibiotic treatment within the previous two weeks.
- 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Lumbar Disc Herniations
|
Primary Outcome(s)
|
Bacterial growth on a per-patient basis
[Time Frame: at time of surgery]
|
Secondary ID(s)
|
S-20140085
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|