Lumbar Disc HerniationsNCT02385968
Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR
An observational study of Lumbar Disc Herniations, run by Spine Centre of Southern Denmark at 1 site in Denmark.
Trial summary
The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Herniations
- How many people
- 5 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2014to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with MRI-confirmed lumbar disc herniation. Lumbar disc herniation. Age between 18 and 65 years. No prior spine surgery. No diagnosed dementia.
Who may be able to join
- MRI-confirmed lumbar disc herniation.
- Age between 18 and 65 years.
- No prior spine surgery.
- No diagnosed dementia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Middelfart Spinesurgery research department
Middelfart, Region Syddanmark, 5500
About this study
The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than patients without Modic changes.
A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.
Read the detailed description
The nucleus material will be evacuated and divided into 5 biopsies, each with a new set of sterile instruments and placed in separate sterile glass vials with one drop of sterile saline to prevent drying of biopsy.
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
- Lumbar Disc Herniations
- Keywords
- Modic, Microbiology, Immunology
- Medical subject headings
- Intervertebral Disc Displacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial growth on a per-patient basis
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2016
Why it stopped: Not possible to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital
- Responsible party
- Principal investigator, Karen Højmark Hansen, Sygehus Lillebaelt
- Investigators
- Karen H. Hansen, Principal investigator, Sygehus Lillebaelt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385968
- Sponsor's protocol ID
- S-20140085
- Status last verified
- Jul 2024
- First submitted
- 4 Mar 2015
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR
- ClinicalTrials.gov ID
- NCT02385968
- Acronym / sponsor ID
- S-20140085
- Conditions
- Lumbar Disc Herniations
- Keywords
- Modic, Microbiology, Immunology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not possible to recruit
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Collaborators
- Vejle Hospital
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than patients without Modic changes.
A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.
Detailed description
The nucleus material will be evacuated and divided into 5 biopsies, each with a new set of sterile instruments and placed in separate sterile glass vials with one drop of sterile saline to prevent drying of biopsy.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with MRI-confirmed lumbar disc herniation. Lumbar disc herniation. Age between 18 and 65 years. No prior spine surgery. No diagnosed dementia.
Key inclusion criteria (4 listed)
- MRI-confirmed lumbar disc herniation.
- Age between 18 and 65 years.
- No prior spine surgery.
- No diagnosed dementia.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial growth on a per-patient basis
Time frame: at time of surgery
Results and safety
The study was stopped early (reason given: Not possible to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen H. Hansen principal investigator
Sygehus Lillebaelt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniations, run by Spine Centre of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not possible to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial growth on a per-patient basis (time frame: at time of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.