Frequency and Characteristics of Low-grade Infections of the Intervertebral Discs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Bacterial growth
研究概览
简要总结
The purpose of this prospective, observational study was to evaluate frequency and characteristics of low-grade infections of the intervertebral discs in an unselected real-life patient population undergoing surgery for degenerative pathologies of the spine.
详细描述
Low-grade infection of the intervertebral discs, causing disc degeneration and consecutive pain and disability is reported in literature. Microorganisms are also held responsible for Modic Changes of the vertebral bodies.
Patients underwent surgery for degenerative pathology of the spine independent of this study. After being informed about this study, all patients giving written informed consent who met eligibility requirements were included. Treatment of the patients was independent of this study. Intraoperative removed disc tissue was examined using microbiological culture, viral polymerase chain reaction (PCR), and histopathological analysis.
Other used data were demographic data (Gender, age), Modic Changes on MRI, preoperative Oswestry Disability Index (ODI), preoperative Neck Disability Index (NDI), and preoperative C-reactive protein (CRP).
Frequency of positive microbiological culture findings, viral PCR, and inflammation signs in histopathological analysis was described, and statistical analysis was performed to identify if any of the above mentioned parameters influences the frequency of positive microbiological culture and Modic Changes significant.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spine surgery including discectomy due to degenerative diseases
- •Availability of removed disc tissue for further analysis
排除标准
- •Signs of spondylodiscitis (clinical signs, inflammation parameters, radiological)
- •Suspected or known tumor disease
- •Traumatic fractures
结局指标
主要结局
Bacterial growth
时间窗: 1 week (Time from surgery until final result of microbiological culture was available)
Number of intervertebral discs with at least one positive microbiological culture result
次要结局
- MC 2(Measured on preoperative MRI (maximum 3 months old))
- CRP(Measured preoperative at hospital admission, i.e. 1-3 days before operation)
- ODI(Measured preoperative at hospital admission, i.e. 1-3 days before operation)
- HSV-1(1 week (Time from surgery until final result of PCR was available))
- HSV-2(1 week (Time from surgery until final result of PCR was available))
- CMV(1 week (Time from surgery until final result of PCR was available))
- MC 1(Measured on preoperative MRI (maximum 3 months old))
- MC 3(Measured on preoperative MRI (maximum 3 months old))
- NDI(Measured preoperative at hospital admission, i.e. 1-3 days before operation)
- Pathology(1 week (Time from surgery until final result of histopathological analyzsis was available))