Detection of Bacteria in Herniated Nucleus Material in Lumbar Disc Herniations by Culture and PCR
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Bacterial growth on a per-patient basis
研究概览
简要总结
The aim is to investigate if herniated nucleus material in lumbar disc herniations is infected with bacteria, and if so, to determine their prevalence (control group), and to determine if patients with pre-existing Modic changes type 1 have a higher incidence of bacterial growth in relevant lumbar disc samples than patients without Modic changes.
A cohort of 15 patients with pre-existing Modic and 15 without-undergoing primary surgery will be examined.
详细描述
The nucleus material will be evacuated and divided into 5 biopsies, each with a new set of sterile instruments and placed in separate sterile glass vials with one drop of sterile saline to prevent drying of biopsy.
The primary outcome, i.e., bacterial growth on a per-patient basis. Bacterial growth shall be detected in minimum 3 out of 5 biopsies for the patient to be scored as positive for bacteria.
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
- 否
入选标准
- •MRI-confirmed lumbar disc herniation.
- •Age between 18 and 65 years.
- •No prior spine surgery.
- •No diagnosed dementia.
排除标准
- •Antibiotic treatment within the previous two weeks.
- •History of alcohol abuse, illicit drug use or drug abuse, or significant mental illness
- •Known immune deficiency state (e.g., positive for human immunodeficiency virus) or in treatment with immunosuppressive drugs including high dose steroids or cyclosporine.
- •Concurrent infections (infections of skin, urinary tract infection, other skin diseases, e.g. Acne vulgaris).
- •Previous epidural instrumentation.
- •Uncontrolled, unstable or recently diagnosed autoimmune disease, including but not limited to systemic lupus erythematosus, inflammatory bowel disease, sarcoidosis, rheumatoid arthritis, or psoriasis.
结局指标
主要结局
Bacterial growth on a per-patient basis
时间窗: at time of surgery
次要结局
未报告次要终点
研究者
Karen Højmark Hansen
Research nurse
Sygehus Lillebaelt