Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT02385968
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:
NCT02385968
Study Brief:
Protocol Section:
NCT02385968