Infection Clinical Trial
— SPInE-IDOfficial title:
Subclinical Propionibacterium Acnes Infection Estimation in the Intervertebral Disc (SPInE-ID): a Prospective Cohort
NCT number | NCT03158766 |
Other study ID # | 2998-17 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 31, 2017 |
Est. completion date | May 22, 2021 |
Verified date | February 2020 |
Source | Hospital Israelita Albert Einstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | May 22, 2021 |
Est. primary completion date | August 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Israelita Albert Einstein | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein | Fundação de Amparo à Pesquisa do Estado de São Paulo |
Brazil,
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. — View Citation
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. Epub 2007 Jul 10. — View Citation
Albert HB, Lambert P, Rollason J, Sorensen JS, Worthington T, Pedersen MB, Nørgaard 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. — View Citation
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. — View Citation
Alcohol drinking. IARC Working Group, Lyon, 13-20 October 1987. IARC Monogr Eval Carcinog Risks Hum. 1988;44:1-378. — View Citation
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. Review. — View Citation
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. Epub 2007 Jun 18. — View Citation
Jensen TS, Karppinen J, Sorensen JS, Niinimäki 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. Review. — View Citation
Modic MT, Masaryk TJ, Ross JS, Carter JR. Imaging of degenerative disk disease. Radiology. 1988 Jul;168(1):177-86. Review. — View Citation
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. — View Citation
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. — View Citation
Oprica C, Emtestam L, Lapins J, Borglund E, Nyberg F, Stenlund K, Lundeberg L, Sillerström 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. — View Citation
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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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Low Back Pain | 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. | At time of patient recruitment and 1, 3, 6 and 12 months after surgical procedure | |
Secondary | EuroQoL-5D - | 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. | At timing of patient recruitment, and 1, 3, 6 and 12 months after surgery. | |
Secondary | Function | 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. | At time of recruitment and 1, 3, 6 and 12 months after surgery. | |
Secondary | Modic incidence | 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 |
1 year after surgery | |
Secondary | Volume of Modic changes | 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). | Preop and 12-month postop acquired MRI studies will be compared. | |
Secondary | Adverse effects | 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. | Through study completion, an average of 1 year after inclusion | |
Secondary | Imaging analysis of edema | Data will be collected for presence of vertebral or disc edema, and presence of disc hydration or not. | Preop and 12-month postop acquired MRI studies will be compared. | |
Secondary | Imaging analysis of disc degeneration | Disc degeneration will be collected as: normal; degeneration with height preservation; and, degeneration with loss of height. Presence of disc hydration or not. | Preop and 12-month postop acquired MRI studies will be compared. |
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