NCT04712487

Low-grade Infections of the Intervertebral Discs

Frequency and Characteristics of Low-grade Infections of the Intervertebral Discs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 392 (actual)
• Sponsor: Kepler University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective, observational study was to evaluate frequency and characteristics of low-grade infections of the intervertebral discs in an unselected real-life patient population undergoing surgery for degenerative pathologies of the spine.

Detailed description

Low-grade infection of the intervertebral discs, causing disc degeneration and consecutive pain and disability is reported in literature. Microorganisms are also held responsible for Modic Changes of the vertebral bodies. Patients underwent surgery for degenerative pathology of the spine independent of this study. After being informed about this study, all patients giving written informed consent who met eligibility requirements were included. Treatment of the patients was independent of this study. Intraoperative removed disc tissue was examined using microbiological culture, viral polymerase chain reaction (PCR), and histopathological analysis. Other used data were demographic data (Gender, age), Modic Changes on MRI, preoperative Oswestry Disability Index (ODI), preoperative Neck Disability Index (NDI), and preoperative C-reactive protein (CRP). Frequency of positive microbiological culture findings, viral PCR, and inflammation signs in histopathological analysis was described, and statistical analysis was performed to identify if any of the above mentioned parameters influences the frequency of positive microbiological culture and Modic Changes significant.

Conditions

• Disc Degeneration

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Microbiological culture, viral PCR, histopathological analysis	Intervertebral disc tissue was sent to the laboratory for further analysis: Microbiological culture: Detection of bacterial growth Viral PCR: Detection of Herpes-Simplex-Type 1 virus, Herpes-Simplex-Type 2 virus, Cytomegalovirus Histopathological analysis: Inflammation signs of disc tissue

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-01-31
• Completion: 2020-10-31
• First posted: 2021-01-15
• Last updated: 2021-01-15

Locations

1 site across 1 country: Austria