Low-grade Infections of the Intervertebral Discs

Disc Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712487
• Other study ID #: EK1078/2018
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: January 2021
• Source: Kepler University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: October 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disc Degeneration
• Infection
• Intervertebral Disc Degeneration

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Neurosurgery, Kepler University Hospital	Linz	Upper Austria

Sponsors (1)

Lead Sponsor	Collaborator
Kepler University Hospital

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	MC 1	Positive Modic Change type 1 in the operated segment	Measured on preoperative MRI (maximum 3 months old)
Secondary	MC 2	Positive Modic Change type 2 in the operated segment	Measured on preoperative MRI (maximum 3 months old)
Secondary	MC 3	Positive Modic Change type 2 in the operated segment	Measured on preoperative MRI (maximum 3 months old)
Secondary	ODI	Oswestry Disability Index, measured only in case of lumbar spine surgery	Measured preoperative at hospital admission, i.e. 1-3 days before operation
Secondary	NDI	Neck Disability Index, measured only in case of cervical spine surgery	Measured preoperative at hospital admission, i.e. 1-3 days before operation
Secondary	CRP	C-reactive protein in mg/dl, measured as blood sample	Measured preoperative at hospital admission, i.e. 1-3 days before operation
Secondary	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)