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

Lumbar Disc Herniations Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02385968
• Other study ID #: S-20140085
• Status: Terminated
• Phase: N/A
• First received: March 4, 2015
• Last updated: December 4, 2017
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: December 2017
• Source: Sygehus Lillebaelt
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 patients without Modic changes.

A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniations

Locations

Country	Name	City	State
Denmark	Middelfart Spinesurgery research department	Middelfart	Region Of Southern Denmark

Sponsors (2)

Lead Sponsor	Collaborator
Sygehus Lillebaelt	Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial growth on a per-patient basis		at time of surgery