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Subclinical Propionibacterium Acnes Infection Estimation in the Intervertebral Disc (SPInE-ID)

NCT03158766 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2021-09-20

No results posted yet for this study

Summary

Subclinical infection of the intervertebral disc after lumbar disc herniation surgery has been correlated to chronic low back pain and vertebral endplate changes. The most commonly reported agent is Propionibacterium acnes. However, the real incidence is unclear, as it has been reported in some series ranging from 3.7% to 46%. Recently, a systematic review concluded that there is a relationship between P. acnes and endplate changes, but, there are so far no studies to verify whether the reported presence of that pathogen in the intervertebral discs is due to local infection or whether intraoperative contamination occurred during the collection of samples.

Thus, the main objective of this study is to estimate the incidence of subclinical infection in patients surgically treated for lumbar disc herniation.

To this end, a prospective cohort study will be conducted with a minimum of 95 patients between 18 and 65 years of age who have been submitted to surgery after failure of conservative treatment. The extruded disc will be removed and cultured for bacterial identification. As controls, the ligamentum flavum and the multifidus muscle, taken respectively before and after removal of the herniated fragment will also be cultured. Patients will be followed-up for a year and MRI will be done at the end of this period.

Conditions

  • Infection
  • Intervertebral Disc Herniation
  • Propionibacterium Infection
  • Spinal Diseases
  • Discitis

Interventions

OTHER

Microdiscectomy

It will be an observational study without interventions. Subjects with diagnose of lumbar disc herniation undergoing open decompression surgery (microdiscectomy) will be included and analyzed. There will be no direct intervention to the patient proposed by the study.

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Delio E Martins Filho, PhD · Hospital Israelita Albert Einstein

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-31
Primary Completion
2019-08-15
Completion
2021-05-22

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03158766 on ClinicalTrials.gov