Clinical Trial (Phase II, Therapeutic Explorative) of the Efficacy of Hybrid Systems in Comparison to the Rigid Spondylodesis in Fusion-surgery in the Lumbar Spine: a Prospective, Randomised, Monocenter Pilotstudy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
This study is designed as a randomized, parallel-group, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to our outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After informed consent and randomization of patients, surgery will be performed. Follow-up examinations will take place immediately after treatment during hospital stay, and then after another 6 and 24 weeks, for a total study duration of 6 months. Data will be assessed after 12, 24 and 36 months for a supplemental investigation. A further assessment will be performed every year, owing to the possibility that a statement regarding ASD cannot be given after 36 months.
Experimental research in this trial will be performed with the approval of the ethics committee of the medical faculty of the University of Cologne and of the university of Halle.
详细描述
Patients over 30 years of age presenting to our outpatient clinic with degenerative disc disease or spondylolisthesis and indications for monosegmental lumbar spine fusion are eligible for trial inclusion. Indication for the fusion procedure will not be stated earlier than after 6 months of conservative therapy. Patients with spondylolisthesis have to respond positively to facet joint injection. Radiologic inclusion criteria are summarized in the appendix.
Prerequisite to inclusion is the presence of radiologic degeneration of the adjacent segment (Pfirrmann grades II-IV in MRI findings) without signs of instability. Definition of radiologic and clinical instability as well as further inclusion criteria are summarized in the appendix.
Study subjects will be approached and recruited by experienced spine surgeons. A number of 150 patients per year, who undergo primary monosegmental fusion in the department, is estimated for the screening procedure. A recruitment rate of 30 patients per year is anticipated.
Patients will receive one of two treatments:
Conventional monosegmental posterior lumbar intervertebral fusion (PLIF) Hybrid system (PLIF + flexible pedicle screw system above the fusion)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >30 years of age
- •Lumbar spine pathology with indication for monosegmental PLIF
- •Radiological signs of a degeneration of the adjacent segment without instability
排除标准
- •Radiological signs of existing instability of the adjacent segment
- •Normal endplates and no disc desiccation in MRI in the adjacent seg-ment
- •Previous surgery of the lumbar spine
结局指标
主要结局
Oswestry Disability Index
时间窗: 6 month
ODI (cross-cultural adaption of the ODI version 2.1 for use with German-speaking patients) - this is one of the condition-specific questionnaires recommended for use with back pain patients. The ODI is a standardized, patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living for those rehabilitating from low back pain. The questionnaire examines perceived level of disability in 10 everyday activities of daily living
次要结局
- COMI questionnaire (version 2008)-(6 weeks, 6, 12, 24, 36 month after baseline)
- Mental Component Summary (MCS) and individual dimensions and subscales of the Mental Component Summary (MCS) and individual dimensions and subscales of SF-36(6 weeks,6, 12,24 and 36 months after baseline)
- SF-36(6 weeks and 6 ,12,24,36 months)
研究者
Dr. Jan Siewe
Dr.med.
University of Cologne