Clinical trial NCT04712487: Low-grade Infections of the Intervertebral Discs
Official title: Frequency and Characteristics of Low-grade Infections of the Intervertebral Discs
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Kepler University Hospital
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary referral center

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.

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

Primary outcomes:
measure: Bacterial growth
timeFrame: 1 week (Time from surgery until final result of microbiological culture was available)
Secondary outcomes:
measure: HSV-1
timeFrame: 1 week (Time from surgery until final result of PCR was available)
measure: HSV-2
timeFrame: 1 week (Time from surgery until final result of PCR was available)
measure: CMV
timeFrame: 1 week (Time from surgery until final result of PCR was available)
measure: MC 1
timeFrame: Measured on preoperative MRI (maximum 3 months old)
measure: MC 2
timeFrame: Measured on preoperative MRI (maximum 3 months old)
measure: MC 3
timeFrame: Measured on preoperative MRI (maximum 3 months old)
measure: ODI
timeFrame: Measured preoperative at hospital admission, i.e. 1-3 days before operation
measure: NDI
timeFrame: Measured preoperative at hospital admission, i.e. 1-3 days before operation
measure: CRP
timeFrame: Measured preoperative at hospital admission, i.e. 1-3 days before operation
measure: Pathology
timeFrame: 1 week (Time from surgery until final result of histopathological analyzsis was available)
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Department of Neurosurgery, Kepler University Hospital
state: Upper Austria
Study officials:
affiliation: Kepler University Hospital
name: Wolfgang Senker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.