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

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ClinicalTrials.gov Identifier: NCT03158766
Recruitment Status : Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : August 31, 2020
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

Brief 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.


Condition or disease Intervention/treatment
Infection Intervertebral Disc Herniation Propionibacterium Infection Spinal Diseases Discitis Other: Microdiscectomy

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Study Type : Observational
Actual Enrollment : 108 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subclinical Propionibacterium Acnes Infection Estimation in the Intervertebral Disc (SPInE-ID): a Prospective Cohort
Actual Study Start Date : May 31, 2017
Actual Primary Completion Date : August 15, 2019
Estimated Study Completion Date : August 22, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Group/Cohort Intervention/treatment
Microdiscectomy
Patients with lumbar disc herniation who failed conservative treatment undergoing surgical treatment through microdiscectomy.
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.




Primary Outcome Measures :
  1. Rate of Intervertebral Disc Infection [ Time Frame: through study completion, an average of 1 year ]

    The main objective of this study considers that the intervertebral disc is infected by any type of low virulence pathogen, which leads to Modic changes and chronic low back pain. Thus, calculation of the incidence of infection in lumbar disc herniations will be performed.

    1. Incidence of infection rate (IIR) will be calculated as follows: IIR = (number of detected infections) (total number of included patients)



Secondary Outcome Measures :
  1. Low Back Pain [ Time Frame: At time of patient recruitment and 1, 3, 6 and 12 months after surgical procedure ]
    Intensity of low back pain and limitation for daily activities of patients with and without infection will be analyzed through the Numeric Rating Score (NRS) system applied at time of patient recruitment and 1, 3, 6 and 12 months after surgical procedure. Minimal clinically important difference will be considered as an increase of 30% of baseline lumbar pain at first postoperative month, due to possible bias of postoperative pain due to surgical manipulation as well as pain due to the disc herniation itself.

  2. Quality of Life [ Time Frame: At timing of patient recruitment, and 1, 3, 6 and 12 months after surgery. ]
    Quality of life at the end of one year for both infected and uninfected groups, with and without Modic changes, will be analyzed through the validated Portuguese version of the EuroQol (EQ-5D) questionnaire. This measurement tool will be applied at timing of patient recruitment, and 1, 3, 6 and 12 months after surgery.

  3. Function [ Time Frame: At time of recruitment and 1, 3, 6 and 12 months after surgery. ]
    Function will be quantified through the Portuguese version of the Oswestry Disability Index (ODI) for lumbar pain that will be applied at time of recruitment and 1, 3, 6 and 12 months after surgery.

  4. Modic incidence [ Time Frame: 1 year after surgery ]

    Insurgent Modic changes in patients will be analyzed one year after surgery, as well as its relationship with presence or absence of infection.

    Incidence of Modic (IM) changes will be calculated for the infection group (IM infec) and for the total group (IM total) as follows:

    (number of Modic changes in infected IM infec = patients after 1 year) (total number of infections)

    IM total = number of Modic changes at final 1 year follow-up total number of patients


  5. Volume of Modic changes [ Time Frame: Preop and 12-month postop acquired MRI studies will be compared. ]
    Modic volume will be measured according to Wang et al(18). Three sagittal slices of the lumbar spine will be considered: midsagittal slice; left pedicle parasagittal slice; and right pedicle parasagittal slice. The parameters examined to quantify Modic changes will include measures of ratios of the region affected by Modic changes to the entire corresponding vertebral body, including maximal width ratio, maximal height ratio, and area ratio. Vertebral body changes will be classified accordingly to Modic changes type I, II, and III(1,2).

  6. Adverse effects [ Time Frame: Through study completion, an average of 1 year after inclusion ]
    Fail of surgical treatment (recurrence, instability, need for reoperation, etc.); need for additional physical therapy sessions; superficial infection; drainage; deep venous thrombosis; and, any other possible adverse event that may show up will be included as well.

  7. Imaging analysis of edema [ Time Frame: Preop and 12-month postop acquired MRI studies will be compared. ]
    Data will be collected for presence of vertebral or disc edema, and presence of disc hydration or not.

  8. Imaging analysis of disc degeneration [ Time Frame: Preop and 12-month postop acquired MRI studies will be compared. ]
    Disc degeneration will be collected as: normal; degeneration with height preservation; and, degeneration with loss of height. Presence of disc hydration or not.


Biospecimen Retention:   Samples Without DNA
Lumbar Intervertebral Disc, Flavum ligament, Multifidus muscle


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with lumbar disc herniation who failed conservative treatment undergoing surgical treatment open decompression surgery (discectomy).
Criteria

Inclusion Criteria:

  • Subjects between 18 and 65 years of age; both genders; with diagnose of lumbar disc herniation undergoing open decompression surgery (microdiscectomy). Patients willing and able to go through all phases of clinical investigation and rehabilitation will be included. An Informed Consent Form (ICF) must be signed.

Exclusion Criteria:

  • Patients with previous lumbar disc surgery at the same level at any point of life; patients undergoing chemotherapy; patients with any immune deficiency; patients previously submitted to disc injection and/or discography; patients submitted to previous endoscopic disc surgery; patients with fusion performed at the same stage of decompression surgery; patients with any other infection within the last six months or usage of antibiotics within the last two months; patients with incomplete specific form or data; decline to participate or sign the ICF.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158766


Locations
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Brazil
Hospital Israelita Albert Einstein
São Paulo, Brazil, 05652-000
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Delio E Martins Filho, PhD Hospital Israelita Albert Einstein
Publications:

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Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03158766    
Other Study ID Numbers: 2998-17
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Israelita Albert Einstein:
infection
intervertebral disc
Propionibacterium acnes
spine
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Discitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylitis
Bone Diseases, Infectious