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

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: Lumbar Disc Herniations

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Spine Centre of Southern Denmark
• Collaborators: Vejle Hospital
• Investigators: Principal Investigator: Karen H. Hansen, Sygehus Lillebaelt

Study record dates

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 (Estimated): March 11, 2015

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Immunology; Microbiology; Modic
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: S-20140085