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

Terminated

• Conditions: Lumbar Disc Herniations

• Registration Number: NCT02385968
• Lead Sponsor: Spine Centre of Southern Denmark

Brief 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 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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-10
• Study First Posted: 2015-03-11
• Primary Completion: 2015-10
• Study Completion: 2016-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bacterial growth on a per-patient basis	at time of surgery

Trial Locations

Locations (1)

Middelfart Spinesurgery research department; 🇩🇰 Middelfart, Region Of Southern Denmark, Denmark