Low-grade Infections of the Intervertebral Discs
- Conditions
- Disc Degeneration
- Interventions
- Diagnostic Test: Microbiological culture, viral PCR, histopathological analysis
- Registration Number
- NCT04712487
- Lead Sponsor
- Kepler University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
- Spine surgery including discectomy due to degenerative diseases
- Availability of removed disc tissue for further analysis
- Signs of spondylodiscitis (clinical signs, inflammation parameters, radiological)
- Suspected or known tumor disease
- Traumatic fractures
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Routine discectomy Microbiological culture, viral PCR, histopathological analysis Patients undergoing routine spine surgery due to degenerative disease of the spine
- Primary Outcome Measures
Name Time Method Bacterial growth 1 week (Time from surgery until final result of microbiological culture was available) Number of intervertebral discs with at least one positive microbiological culture result
- Secondary Outcome Measures
Name Time Method MC 2 Measured on preoperative MRI (maximum 3 months old) Positive Modic Change type 2 in the operated segment
CRP Measured preoperative at hospital admission, i.e. 1-3 days before operation C-reactive protein in mg/dl, measured as blood sample
ODI Measured preoperative at hospital admission, i.e. 1-3 days before operation Oswestry Disability Index, measured only in case of lumbar spine surgery
HSV-1 1 week (Time from surgery until final result of PCR was available) Number of intervertebral discs with at least one positive result for Herpes-Simplex-Virus type 1
HSV-2 1 week (Time from surgery until final result of PCR was available) Number of intervertebral discs with at least one positive result for Herpes-Simplex-Virus type 2
CMV 1 week (Time from surgery until final result of PCR was available) Number of intervertebral discs with at least one positive result for Cytomegalovirus
MC 1 Measured on preoperative MRI (maximum 3 months old) Positive Modic Change type 1 in the operated segment
MC 3 Measured on preoperative MRI (maximum 3 months old) Positive Modic Change type 2 in the operated segment
NDI Measured preoperative at hospital admission, i.e. 1-3 days before operation Neck Disability Index, measured only in case of cervical spine surgery
Pathology 1 week (Time from surgery until final result of histopathological analyzsis was available) Positive inflammation signs in histopathological analysis. Analyzed for each collected intervertebral disc
Trial Locations
- Locations (1)
Department of Neurosurgery, Kepler University Hospital
🇦🇹Linz, Upper Austria, Austria