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Low-grade Infections of the Intervertebral Discs

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04712487
Enrollment
392
Registered
2021-01-15
Start date
2018-12-01
Completion date
2020-10-31
Last updated
2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disc Degeneration

Keywords

low-grade infection, intervertebral disc, spine, cutibacterium acnes, culture, herpes simplex, modic changes, CRP, histopathology, microbiology, oswestry disability index, neck disability index

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.

Interventions

DIAGNOSTIC_TESTMicrobiological 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

Sponsors

Kepler University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bacterial growth1 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

MeasureTime frameDescription
HSV-21 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
CMV1 week (Time from surgery until final result of PCR was available)Number of intervertebral discs with at least one positive result for Cytomegalovirus
MC 1Measured on preoperative MRI (maximum 3 months old)Positive Modic Change type 1 in the operated segment
MC 2Measured on preoperative MRI (maximum 3 months old)Positive Modic Change type 2 in the operated segment
HSV-11 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
ODIMeasured preoperative at hospital admission, i.e. 1-3 days before operationOswestry Disability Index, measured only in case of lumbar spine surgery
NDIMeasured preoperative at hospital admission, i.e. 1-3 days before operationNeck Disability Index, measured only in case of cervical spine surgery
CRPMeasured preoperative at hospital admission, i.e. 1-3 days before operationC-reactive protein in mg/dl, measured as blood sample
Pathology1 week (Time from surgery until final result of histopathological analyzsis was available)Positive inflammation signs in histopathological analysis. Analyzed for each collected intervertebral disc
MC 3Measured on preoperative MRI (maximum 3 months old)Positive Modic Change type 2 in the operated segment

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026