Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR

December 4, 2017 updated by: Karen Hoejmark Hansen, Sygehus Lillebaelt

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.

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Of Southern Denmark
      • Middelfart, Region Of Southern Denmark, Denmark, 5500
        • Middelfart Spinesurgery research department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bacterial growth on a per-patient basis
Time Frame: at time of surgery
at time of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sygehus Lillebaelt

Collaborators

Vejle Hospital

Investigators

  • Principal Investigator: Karen H. Hansen, Sygehus Lillebaelt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 4, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20140085

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Disc Herniations

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe