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

NCT03158766 | Completed DMC

• 1 other identifier: 2998-17
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

infection; intervertebral disc; Propionibacterium acnes; spine

Outcome Measures

Primary Outcomes (1)

• Rate of Intervertebral Disc Infection

  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)

  through study completion, an average of 1 year

Secondary Outcomes (8)

• Low Back Pain

  At time of patient recruitment and 1, 3, 6 and 12 months after surgical procedure

• EuroQoL-5D -

  At timing of patient recruitment, and 1, 3, 6 and 12 months after surgery.

• Function

  At time of recruitment and 1, 3, 6 and 12 months after surgery.

• Modic incidence

  1 year after surgery

• Volume of Modic changes

  Preop and 12-month postop acquired MRI studies will be compared.

Study Arms (1)

Microdiscectomy

Patients with lumbar disc herniation who failed conservative treatment undergoing surgical treatment through microdiscectomy.

Other: Microdiscectomy

Interventions

Microdiscectomy OTHER

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.

Microdiscectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with lumbar disc herniation who failed conservative treatment undergoing surgical treatment open decompression surgery (discectomy).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652-000, Brazil

Location

Related Publications (14)

• Modic MT, Steinberg PM, Ross JS, Masaryk TJ, Carter JR. Degenerative disk disease: assessment of changes in vertebral body marrow with MR imaging. Radiology. 1988 Jan;166(1 Pt 1):193-9. doi: 10.1148/radiology.166.1.3336678.

  PMID: 3336678 BACKGROUND

• Modic MT, Masaryk TJ, Ross JS, Carter JR. Imaging of degenerative disk disease. Radiology. 1988 Jul;168(1):177-86. doi: 10.1148/radiology.168.1.3289089. No abstract available.

  PMID: 3289089 BACKGROUND

• Jensen TS, Karppinen J, Sorensen JS, Niinimaki J, Leboeuf-Yde C. Vertebral endplate signal changes (Modic change): a systematic literature review of prevalence and association with non-specific low back pain. Eur Spine J. 2008 Nov;17(11):1407-22. doi: 10.1007/s00586-008-0770-2. Epub 2008 Sep 12.

  PMID: 18787845 BACKGROUND

• Toyone T, Takahashi K, Kitahara H, Yamagata M, Murakami M, Moriya H. Vertebral bone-marrow changes in degenerative lumbar disc disease. An MRI study of 74 patients with low back pain. J Bone Joint Surg Br. 1994 Sep;76(5):757-64.

  PMID: 8083266 BACKGROUND

• Albert HB, Kjaer P, Jensen TS, Sorensen JS, Bendix T, Manniche C. Modic changes, possible causes and relation to low back pain. Med Hypotheses. 2008;70(2):361-8. doi: 10.1016/j.mehy.2007.05.014. Epub 2007 Jul 10.

  PMID: 17624684 BACKGROUND

• Ohtori S, Koshi T, Yamashita M, Yamauchi K, Inoue G, Suzuki M, Takaso M, Orita S, Eguchi Y, Ochiai N, Kishida S, Kuniyoshi K, Nakamura J, Aoki Y, Ishikawa T, Arai G, Miyagi M, Kamoda H, Takahashi K. Existence of pyogenic spondylitis in Modic type 1 change without other signs of infection: 2-year follow-up. Eur Spine J. 2010 Jul;19(7):1200-5. doi: 10.1007/s00586-010-1358-1. Epub 2010 Mar 8.

  PMID: 20213295 BACKGROUND

• Albert HB, Sorensen JS, Christensen BS, Manniche C. Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Eur Spine J. 2013 Apr;22(4):697-707. doi: 10.1007/s00586-013-2675-y. Epub 2013 Feb 13.

  PMID: 23404353 BACKGROUND

• Albert HB, Lambert P, Rollason J, Sorensen JS, Worthington T, Pedersen MB, Norgaard HS, Vernallis A, Busch F, Manniche C, Elliott T. Does nuclear tissue infected with bacteria following disc herniations lead to Modic changes in the adjacent vertebrae? Eur Spine J. 2013 Apr;22(4):690-6. doi: 10.1007/s00586-013-2674-z. Epub 2013 Feb 10.

  PMID: 23397187 BACKGROUND

• 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: 11438138 BACKGROUND

• Agarwal V, Golish SR, Alamin TF. Bacteriologic culture of excised intervertebral disc from immunocompetent patients undergoing single level primary lumbar microdiscectomy. J Spinal Disord Tech. 2011 Aug;24(6):397-400. doi: 10.1097/BSD.0b013e3182019f3a.

  PMID: 21150662 BACKGROUND

• Carricajo A, Nuti C, Aubert E, Hatem O, Fonsale N, Mallaval FO, Vautrin AC, Brunon J, Aubert G. Propionibacterium acnes contamination in lumbar disc surgery. J Hosp Infect. 2007 Jul;66(3):275-7. doi: 10.1016/j.jhin.2007.04.007. Epub 2007 Jun 18.

  PMID: 17573158 BACKGROUND

• Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.

  PMID: 18487245 BACKGROUND

• Oprica C, Emtestam L, Lapins J, Borglund E, Nyberg F, Stenlund K, Lundeberg L, Sillerstrom E, Nord CE. Antibiotic-resistant Propionibacterium acnes on the skin of patients with moderate to severe acne in Stockholm. Anaerobe. 2004 Jun;10(3):155-64. doi: 10.1016/j.anaerobe.2004.02.002.

  PMID: 16701513 BACKGROUND

• Alcohol drinking. IARC Monogr Eval Carcinog Risks Hum. 1988;44:1-378. No abstract available.

  PMID: 3236394 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Lumbar Intervertebral Disc, Flavum ligament, Multifidus muscle

MeSH Terms

Conditions

Infections; Intervertebral Disc Displacement; Spinal Diseases; Discitis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylitis; Bone Diseases, Infectious

Study Officials

• Delio E Martins Filho, PhD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 18, 2017
• Study Start: May 31, 2017
• Primary Completion: August 15, 2019
• Study Completion: May 22, 2021
• Last Updated: September 20, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)