NCT04712487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
392

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

January 13, 2021

Last Update Submit

January 13, 2021

Conditions

Disc Degeneration

Keywords

low-grade infectionintervertebral discspinecutibacterium acnescultureherpes simplexmodic changesCRPhistopathologymicrobiologyoswestry disability indexneck disability index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • HSV-1

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

  • HSV-2

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

  • CMV

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

  • MC 1

    Measured on preoperative MRI (maximum 3 months old)

  • MC 2

    Measured on preoperative MRI (maximum 3 months old)

  • +5 more secondary outcomes

Study Arms (1)

Routine discectomy

Patients undergoing routine spine surgery due to degenerative disease of the spine

Diagnostic Test: Microbiological culture, viral PCR, histopathological analysis

Interventions

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

Routine discectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary referral center

You may qualify if:

  • Spine surgery including discectomy due to degenerative diseases
  • Availability of removed disc tissue for further analysis

You may not qualify if:

  • Signs of spondylodiscitis (clinical signs, inflammation parameters, radiological)
  • Suspected or known tumor disease
  • Traumatic fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Kepler University Hospital

Linz, Upper Austria, 4020, Austria

Location

Related Publications (3)

  • 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.

    PMID: 30575599BACKGROUND

  • 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.

    PMID: 11438138BACKGROUND

  • 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.

    PMID: 35303173DERIVED

MeSH Terms

Conditions

Intervertebral Disc DegenerationHerpes Simplex

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wolfgang Senker, MD

    Kepler University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 15, 2021

Study Start

December 1, 2018

Primary Completion

January 31, 2020

Study Completion

October 31, 2020

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)