Disc DegenerationNCT04712487
Low-grade Infections of the Intervertebral Discs
An observational study of Disc Degeneration, run by Kepler University Hospital at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disc Degeneration
- What is being tested?
- Microbiological culture, viral PCR, histopathological analysis
- How many people
- 392 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2018to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary referral center
Who may be able to join
- Spine surgery including discectomy due to degenerative diseases
- Availability of removed disc tissue for further analysis
Who cannot join
- Signs of spondylodiscitis (clinical signs, inflammation parameters, radiological)
- Suspected or known tumor disease
- Traumatic fractures
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Neurosurgery, Kepler University Hospital
Linz, Upper Austria, 4020
About this study
Official title: 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.
Read the 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.
- Conditions
- Disc Degeneration
- Being tested
- Microbiological culture, viral PCR, histopathological analysis
- Keywords
- low-grade infection, intervertebral disc, spine, cutibacterium acnes, culture, herpes simplex, modic changes, CRP, histopathology, microbiology, oswestry disability index, neck disability index
- Medical subject headings
- Intervertebral Disc Degeneration, Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological culture, viral PCR, histopathological analysisDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Routine discectomy | Patients undergoing routine spine surgery due to degenerative disease of the spine Receives: Diagnostic Test: Microbiological culture, viral PCR, histopathological analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial growth
Number of intervertebral discs with at least one positive microbiological culture result
Measured: 1 week (Time from surgery until final result of microbiological culture was available)
Secondary outcomes (10)
HSV-1
Number of intervertebral discs with at least one positive result for Herpes-Simplex-Virus type 1
Measured: 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
Measured: 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
Measured: 1 week (Time from surgery until final result of PCR was available)
MC 1
Positive Modic Change type 1 in the operated segment
Measured: Measured on preoperative MRI (maximum 3 months old)
MC 2
Positive Modic Change type 2 in the operated segment
Measured: Measured on preoperative MRI (maximum 3 months old)
MC 3
Positive Modic Change type 2 in the operated segment
Measured: Measured on preoperative MRI (maximum 3 months old)
ODI
Oswestry Disability Index, measured only in case of lumbar spine surgery
Measured: 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: Measured preoperative at hospital admission, i.e. 1-3 days before operation
CRP
C-reactive protein in mg/dl, measured as blood sample
Measured: 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
Measured: 1 week (Time from surgery until final result of histopathological analyzsis was available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start1 Dec 2018
- Primary completion31 Jan 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wolfgang Senker, MD, Principal investigator, Kepler University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712487
- Sponsor's protocol ID
- EK1078/2018
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2021
- Last updated
- 15 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30575599Stirling 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.
PubMed 11438138Senker 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.
PubMed 35303173
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Characteristics of Low-grade Infections of the Intervertebral Discs
- ClinicalTrials.gov ID
- NCT04712487
- Acronym / sponsor ID
- EK1078/2018
- Conditions
- Disc Degeneration
- Keywords
- low-grade infection, intervertebral disc, spine, cutibacterium acnes, culture, herpes simplex, modic changes, CRP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 15 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine discectomy | – | Diagnostic Test: Microbiological culture, viral PCR, histopathological analysisPatients undergoing routine spine surgery due to degenerative disease of the spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary referral center
Key inclusion criteria (2 listed)
- Spine surgery including discectomy due to degenerative diseases
- Availability of removed disc tissue for further analysis
Key exclusion criteria (3 listed)
- Signs of spondylodiscitis (clinical signs, inflammation parameters, radiological)
- Suspected or known tumor disease
- Traumatic fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiological culture, viral PCR, histopathological analysisIntervertebral 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 | Diagnostic test | Routine discectomy |
Primary outcome
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
10 secondary outcomes
HSV-1
Time frame: 1 week (Time from surgery until final result of PCR was available)
HSV-2
Time frame: 1 week (Time from surgery until final result of PCR was available)
CMV
Time frame: 1 week (Time from surgery until final result of PCR was available)
MC 1
Time frame: Measured on preoperative MRI (maximum 3 months old)
MC 2
Time frame: Measured on preoperative MRI (maximum 3 months old)
MC 3
Time frame: Measured on preoperative MRI (maximum 3 months old)
ODI
Time frame: Measured preoperative at hospital admission, i.e. 1-3 days before operation
NDI
Time frame: Measured preoperative at hospital admission, i.e. 1-3 days before operation
CRP
Time frame: Measured preoperative at hospital admission, i.e. 1-3 days before operation
Pathology
Time frame: 1 week (Time from surgery until final result of histopathological analyzsis was available)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2021.
- Background: PubMed 30575599Iyer 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.
- Background: PubMed 11438138Stirling 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.
- Derived from this study: PubMed 35303173Senker 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Senker, MD principal investigator
Kepler University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disc Degeneration, run by Kepler University Hospital at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial growth (time frame: 1 week (Time from surgery until final result of microbiological culture was available)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04712487, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2021.