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临床试验/NCT03158766
NCT03158766已完成不适用

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

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2017年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
1
主要终点
Rate of Intervertebral Disc Infection

研究概览

简要总结

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.

详细描述

INTRODUCTION Low back pain is a frequent condition in the population, as well as vertebral endplates abnormalities, described by Modic et al.(1,2), that affect up to 6% of the general population, and, up to 46% of patients with low back pain(3). Modic type I changes are described as vertebral bone marrow edema related to acute low back pain(4). When Modic changes are detected, chances of one presenting unspecific low back pain are 4.5 times higher(1,2).

Subclinical infection caused by low-virulence pathogen can possibly lead to vertebral endplate abnormalities, detected in magnetic resonance imaging (MRI) studies, and differentiation between infection and Modic changes may be difficult(5,6). Subclinical infection can also be associated with increasing low back pain(7). Albert et al(8) reported 61 patients who had undergone surgical treatment for lumbar disc herniation where 46% of cases had a positive culture. The same authors also reported that 80% of patients with a positive culture for anaerobic pathogens presented Modic type I changes at the adjacent vertebra after a two-year follow-up, against 44% of patients with negative culture. Some studies demonstrated the presence of low-virulence pathogens in intervertebral disc tissue cultures(6-10), most commonly reported to Propionibacterium acnes.

Chronic low back pain and Modic type I changes have been treated with antibiotics for up to 100 days with superior outcomes compared to sham treatment(7). Patients were treated with amoxicillin/clavulanate (500mg/125mg)(7) based on the study where sciatica is associated with Propionibacterium acnes(8).

However, Carricajo et al(11) suggest that the presence of P. acnes in the intervertebral discs is due to either external surgical or laboratory contamination. These authors detected positive disc culture in only 3.7% of cases out of 54 patients. Furthermore, same authors demonstrated that samples of spinal muscle and ligamentum flavum collected intraoperatively at the end of procedure had positive cultures in 14.8% of cases with a negative disc culture.

A systematic review performed by Urquhart et al(12) concluded, that there is moderate evidence that a relationship between positive culture with Modic type I changes and low back pain exists, although there was low evidence for relationship of cause. For that, authors concluded that new studies should be made to determine whether pathogens in the disc are originated from external contamination or if they are truly involved in the development of chronic back pain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Rate of Intervertebral Disc Infection

时间窗: 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)

次要结局

  • EuroQoL-5D -(At timing of patient recruitment, and 1, 3, 6 and 12 months after surgery.)
  • Low Back Pain(At time of patient recruitment and 1, 3, 6 and 12 months after surgical procedure)
  • Function(At time of recruitment and 1, 3, 6 and 12 months after surgery.)
  • Imaging analysis of edema(Preop and 12-month postop acquired MRI studies will be compared.)
  • Imaging analysis of disc degeneration(Preop and 12-month postop acquired MRI studies will be compared.)
  • Modic incidence(1 year after surgery)
  • Volume of Modic changes(Preop and 12-month postop acquired MRI studies will be compared.)
  • Adverse effects(Through study completion, an average of 1 year after inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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