The Role of Cutibacterium Acnes in the Development of Degenerative Lumbar Intervertebral Disc Disease and the Clinical Effect of Microdiscectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The effect of C. acnes on functional disability in patients after microdiscectomy.
研究概览
简要总结
The goal of this study is to clarify the role of the bacterium Cutibacterium acnes in the development of degenerative disc disease in patients with lumbar disc herniation who underwent microdiscectomy as part of their regular medical care.
详细描述
The project is divided into retrospective and prospective parts. The retrospective part will consist of data processing and analysis using our large cohort of patients enrolled during the previous studies. The prospective part will include a) patient enrollment, b) preoperative data collection, c) perioperative tissue collection, d) microbiological examination, e) postoperative follow-up visits, and f) data management and statistical analyses.
Retrospective data processing and analysis For the retrospective part of the project, the investigators plan to use the C. acnes database stored at the Department of Neurosurgery, St. Anne's University Hospital, Brno, Czech Republic. This database contains 1200 anonymized adult patients with symptomatic lumbar disc herniation scheduled for microdiscectomy between 2015 and 2024. These patients were enrolled during the research project entitled "Presence of the low-virulence bacterium Propionibacterium acnes in the intervertebral disc tissue as a cause of chronic back pain". Each patient signed informed consent forms before enrolling in this study, enabling future data analyses. According to our preliminary review, at least 400 patients of the retrospective cohort have completed epidemiologic, MRI, microbiological, and clinical data. The epidemiological data include age, gender, disc herniation relapse, epidural steroid injection before the surgery, body mass index (BMI), the lumbar segment of herniation, type of herniation, and physical workload. The clinical data include microbiological findings from perioperatively collected disc tissue, preoperative spinal MRI, preoperative and postoperative pain intensity according to the visual analog scale (VAS), and functional disability for low back pain quantified by the Oswestry Disability Questionnaire (ODQ). Although the data is available, no hypotheses between C. acnes positivity and clinical outcomes have yet been tested on the dataset. Therefore, in this part of the project, microbiological findings will be studied together with radiological changes in preoperative MRI and clinical status before and after surgery.
Prospective data cohort
Patient enrollment - the investigators plan to enrol at least 400 patients with lumbar disc herniation indicated for microdiscectomy at the Department of Neurosurgery, Faculty of Medicine, Masaryk University and St. Anne's University Hospital, Brno, Czech Republic. Patients indicated for lumbar microdiscectomy will be prospectively screened, and those who pass the inclusion and exclusion criteria will be asked to sign the Informed Consent form to be enrolled in the study.
Preoperative data collection - baseline epidemiological and clinical data such as age, gender, disc herniation relapse, epidural steroid injection before the surgery, body mass index (BMI), the lumbar segment of herniation, type of herniation, and physical workload will be collected from each patient. Degenerative changes in the intervertebral discs and adjacent spinal structures will be evaluated on MRI as part of a standard preoperative examination. Clinical data will be obtained during the preoperative clinical exam and from patients in the form of questionnaires, including a numerical scale for leg and back pain, the Oswestry questionnaire evaluating the impact of low back pain on activities of daily living, and the Short Form quality of life questionnaire - 36 (SF- 36) to examine the quality of life before surgery.
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
- •minimum age of 18 years
- •MRI of the lumbosacral spine performed one month ± 2weeks before surgery showing a disc protrusion, herniation, or free nucleus pulposus sequestration
- •matching physical examination findings including positive straight leg raise test, dermatomal sensory deficits, myotome motor deficits, and diminished deep tendon reflexes.
排除标准
- •antibiotics or corticosteroid use the month before surgery
- •ongoing bacterial or viral infection
- •immunocompromised patient
- •undefined radiological mass
- •inflammatory arthritis
- •other rheumatologic diseases.
结局指标
主要结局
The effect of C. acnes on functional disability in patients after microdiscectomy.
时间窗: 6 weeks (± 1week) after the operation.
The primary aim is a questionnaire-based comparison of the dynamics of the functional limitations according to ODI score between patients with different C. acnes bacterial load and C. acnes isolates in the disc tissue following microdiscectomy.
次要结局
- The effect of C. acnes on functional disability in patients after microdiscectomy.(12 months (± 2weeks) after the operation.)
- The effect of C. acnes on radicular pain in patients after microdiscectomy.(12 months (± 2weeks) after the operation.)
- The effect of C. acnes on low back pain in patients after microdiscectomy.(12 months (± 2weeks) after the operation.)
- The effect of C. acnes on quality of life in patients after microdiscectomy.(12 months (± 2weeks) after the operation.)
- The influence of C. acnes on the success of surgical treatment in patients after microdiscectomy.(12 months (± 2weeks) after the operation.)
- The influence of C. acnes on patient satisfaction after microdiscectomy.(12 months (± 2weeks) after the operation.)
- Presence of other bacteria in disc tissue and their effect on radicular pain in patients after microdiscectomy.(6 months (± 2weeks) after the operation.)
- Presence of other bacteria in disc tissue and their effect on radicular pain in patients after microdiscectomy(12 months (± 2weeks) after the operation.)
- Presence of other bacteria in disc tissue and their effect on low back pain in patients after microdiscectomy(12 months (± 2weeks) after the operation.)
- Presence of other bacteria in disc tissue and their effect on low back pain in patients after microdiscectomy.(6 months (± 2weeks) after the operation.)
- Presence of other bacteria in disc tissue and their effect on functional disability in patients after microdiscectomy.(6 weeks (± 1week) after the operation.)
- Presence of other bacteria in disc tissue and their effect on functional disability in patients after microdiscectomy(12 months (± 2weeks) after the operation.)
- Presence of other bacteria in disc tissue and their effect on the quality of life in patients after microdiscectomy.(12 months (± 2weeks) after the operation.)
- Presence of other bacteria in disc tissue and their role in the success of surgical treatment in patients after microdiscectomy(12 months (± 2weeks) after the operation.)
- The presence of other bacteria in disc tissue and their role in patient satisfaction after microdiscectomy(12 months (± 2weeks) after the operation.)
- Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on preoperative radicular pain.(Processing of retrospective data up to one year after the start of the study.)
- Retrospective evaluation of the effect of different C. acnes bacterial load in disc tissue on preoperative low back pain.(Processing of retrospective data up to one year after the start of the study.)
- Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on preoperative functional disability(Processing of retrospective data up to one year after the start of the study)
- Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on the occurrence of Modic changes on preoperative MRI(Processing of retrospective data up to one year after the start of the study.)
- Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on the severity of degenerative changes in the intervertebral disc.(Processing of retrospective data up to one year after the start of the study)
- Retrospective evaluation of the influence of different C. acnes bacterial load in disc tissue on the severity of vertebral endplate damage.(Processing of retrospective data up to one year after the start of the study.)
