Low-grade Infections of the Intervertebral Discs

Frequency and Characteristics of 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.

Study Overview

• Status: Completed
• Conditions: Disc Degeneration
• Intervention / Treatment: Diagnostic test: Microbiological culture, viral PCR, histopathological analysis

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.

• Study Type: Observational
• Enrollment (Actual): 392

Contacts and Locations

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Department of Neurosurgery, Kepler University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Tertiary referral center

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Routine discectomy; Patients undergoing routine spine surgery due to degenerative disease of the spine	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

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)

Collaborators and Investigators

• Sponsor: Kepler University Hospital
• Investigators: Principal Investigator: Wolfgang Senker, MD, Kepler University Hospital

Publications and helpful links

General Publications

• Iyer S, Louie PK, Nolte MT, Phillips FM. The Relationship Between Low-Grade Infection and Degenerative Disk Disease: A Review of Basic Science and Clinical Data. J Am Acad Orthop Surg. 2019 Jul 15;27(14):509-518. doi: 10.5435/JAAOS-D-18-00257.
• Stirling A, Worthington T, Rafiq M, Lambert PA, Elliott TS. Association between sciatica and Propionibacterium acnes. Lancet. 2001 Jun 23;357(9273):2024-5. doi: 10.1016/S0140-6736(00)05109-6. No abstract available.
• Senker W, Aspalter S, Radl C, Pichler J, Doppler S, Weis S, Webersinke C, Wagner H, Hermann P, Aichholzer M, Aufschnaiter-Hiessbock K, Thomae W, Stroh N, Hauser T, Gruber A. Frequency and characteristics of bacterial and viral low-grade infections of the intervertebral discs: a prospective, observational study. J Orthop Traumatol. 2022 Mar 18;23(1):15. doi: 10.1186/s10195-022-00633-y.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2018
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ACTUAL): October 31, 2020

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (ACTUAL): January 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: intervertebral disc; microbiology; spine; herpes simplex; culture; CRP; histopathology; low-grade infection; cutibacterium acnes; modic changes; oswestry disability index; neck disability index
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Infections; Intervertebral Disc Degeneration
• Other Study ID Numbers: EK1078/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No