CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
Microdiscectomyother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03158766
NCT03158766N/ACompleted

Subclinical Propionibacterium Acnes Infection Estimation in the Intervertebral Disc (SPInE-ID): a Prospective Cohort

Hospital Israelita Albert Einstein·observational·Posted May 18, 2017·Updated Sep 20, 2021

In Brief

An observational study evaluating Microdiscectomy for Infection and 4 related conditions. Completed, enrolled 108 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 18, 2017
Enrollment StartMay 31, 2017
Primary CompletionAug 15, 2019
Study CompletionMay 22, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.1 years ago

Interventions

Microdiscectomyother

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.