Skip to main content
OpenTrials
Completed

NCT Number: NCT04712487

Low-grade Infections of the Intervertebral Discs

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Disc Degeneration Bone Diseases DNA Virus Infections Herpes Simplex Herpesviridae Infections Infections Intervertebral Disc Degeneration Musculoskeletal Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Spinal Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurosurgery, Kepler University Hospital

Linz, Upper Austria, 4020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbiological culture, viral PCR, histopathological analysis

Diagnostic Test

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

Primary outcomes

  1. Bacterial growth

    Time frame: 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 outcomes

  1. HSV-1

    Time frame: 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

  2. HSV-2

    Time frame: 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

  3. CMV

    Time frame: 1 week (Time from surgery until final result of PCR was available)

    Number of intervertebral discs with at least one positive result for Cytomegalovirus

  4. MC 1

    Time frame: Measured on preoperative MRI (maximum 3 months old)

    Positive Modic Change type 1 in the operated segment

  5. MC 2

    Time frame: Measured on preoperative MRI (maximum 3 months old)

    Positive Modic Change type 2 in the operated segment

  6. MC 3

    Time frame: Measured on preoperative MRI (maximum 3 months old)

    Positive Modic Change type 2 in the operated segment

  7. ODI

    Time frame: Measured preoperative at hospital admission, i.e. 1-3 days before operation

    Oswestry Disability Index, measured only in case of lumbar spine surgery

  8. NDI

    Time frame: Measured preoperative at hospital admission, i.e. 1-3 days before operation

    Neck Disability Index, measured only in case of cervical spine surgery

  9. CRP

    Time frame: Measured preoperative at hospital admission, i.e. 1-3 days before operation

    C-reactive protein in mg/dl, measured as blood sample

  10. Pathology

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.