Low-grade Infections of the Intervertebral Discs

Study Overview
=================
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.

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

Conditions
-----------------
Disc Degeneration

Intervention / Treatment
-----------------
* Diagnostic Test: Microbiological culture, viral PCR, histopathological analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Spine surgery including discectomy due to degenerative diseases Availability of removed disc tissue for further analysis Exclusion Criteria: Signs of spondylodiscitis (clinical signs, inflammation parameters, radiological) Suspected or known tumor disease Traumatic fractures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Routine discectomy<br>Patients undergoing routine spine surgery due to degenerative disease of the spine | Diagnostic Test: Microbiological culture, viral PCR, histopathological analysis<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial growth | Number of intervertebral discs with at least one positive microbiological culture result | 1 week (Time from surgery until final result of microbiological culture was available) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HSV-1 | Number of intervertebral discs with at least one positive result for Herpes-Simplex-Virus type 1 | 1 week (Time from surgery until final result of PCR was available) | 
| HSV-2 | Number of intervertebral discs with at least one positive result for Herpes-Simplex-Virus type 2 | 1 week (Time from surgery until final result of PCR was available) | 
| CMV | Number of intervertebral discs with at least one positive result for Cytomegalovirus | 1 week (Time from surgery until final result of PCR was available) | 
| MC 1 | Positive Modic Change type 1 in the operated segment | Measured on preoperative MRI (maximum 3 months old) | 
| MC 2 | Positive Modic Change type 2 in the operated segment | Measured on preoperative MRI (maximum 3 months old) | 
| MC 3 | Positive Modic Change type 2 in the operated segment | Measured on preoperative MRI (maximum 3 months old) | 
| ODI | Oswestry Disability Index, measured only in case of lumbar spine surgery | Measured preoperative at hospital admission, i.e. 1-3 days before operation | 
| NDI | Neck Disability Index, measured only in case of cervical spine surgery | Measured preoperative at hospital admission, i.e. 1-3 days before operation | 
| CRP | C-reactive protein in mg/dl, measured as blood sample | Measured preoperative at hospital admission, i.e. 1-3 days before operation | 
| Pathology | Positive inflammation signs in histopathological analysis. Analyzed for each collected intervertebral disc | 1 week (Time from surgery until final result of histopathological analyzsis was available) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRP, low-grade infection, intervertebral disc, spine, cutibacterium acnes, culture, herpes simplex, modic changes, histopathology, microbiology, oswestry disability index, neck disability index