NCT02385968

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Spine Centre of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lumbar Disc Herniations

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-10-01
• Completion: 2016-10-01
• First posted: 2015-03-11
• Last updated: 2024-07-30

Locations

1 site across 1 country: Denmark