Short-term Clinical Outcome of Cortical Bone Trajectory Compared With the Traditional "Open" and Minimal Invasive Posterior Lumbar Interbody Fusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- VAS low back pain
研究概览
简要总结
A combined prospective cohort study and retrospective analysis of previously collected data. Three different techniques for posterior lumbar interbody fusion (PLIF) are compared: CBT-PLIF, MI-PLIF and open PLIF. A total of 180 patients are included, who will be followed up to 6 weeks postoperatively.
详细描述
A combined prospective cohort study for CBT-PLIF and retrospective analysis of prospectively collected data from the MISOS study, regarding traditional open PLIF and MI-PLIF. A total of 180 patients will be included in the study: 60 prospective CBT-PLIF patients, 60 retrospective open PLIF patients and 60 retrospective MI-PLIF patients.
The new data will be collected prospectively by means of questionnaires. No biomaterial will be collected. The included patients will be asked to complete questionnaires before surgery, 2 and 6 weeks after surgery. In addition, VAS scores will be noted throughout the hospital stay, 2 and 6 weeks after surgery.
Inclusion criteria: Patients aged 18-75 years with neurogenic claudication and/or radicular leg pain due to low-grade (Meyerding grades l and ll) degenerative or spondylolytic spondylolisthesis with persistent symptoms for more than 3 months.
Exclusion criteria: previous spinal fusion surgery at the same level, osteoporosis (only when using bisphosphonate), active infection or previous infection at the surgical site, active cancer, spondylolisthesis grade III or greater, more than one symptomatic level requiring fusion, pregnancy, contraindication to surgery, severe mental or psychiatric disorder, substance abuse, insufficient knowledge of the Dutch language and morbid obesity (body mass index >40).
Main research question: Does the CBT-PLIF provide less low back pain in the short term than the traditional open PLIF and the MI-PLIF?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years
- •Degenerative or spondylolytic spondylolisthesis
- •Neurogenic claudication and/or radicular leg pain
- •Low grade (Meyerding grade l and ll)
- •Persistent complaints for over 3 months
排除标准
- •Previous spine fusion surgery at the same level
- •Osteoporosis
- •Active infection or prior infection at the surgical site
- •Active cancer
- •Spondylolisthesis grade lll or greater
- •More than one symptomatic level that needs fusion
- •Pregnancy
- •Contraindication for surgery
- •Severe mental or psychiatric disorder
- •Substance abuse
- •Inadequate knowledge of Dutch language
- •Morbid obesity (body mass index >40)
结局指标
主要结局
VAS low back pain
时间窗: 2 weeks postoperative
VAS for low back pain ranging from 0mm (no pain) to 100mm (worst pain imaginable)
次要结局
- Oswestry Disability Index(2 and 6 weeks postoperative)
- VAS low back pain(During hospital stay, measured each day and 6 weeks postoperative)
- Perceived recovery of the patient(2 and 6 weeks postoperative)
- VAS leg pain(During hospital stay, measured each day, 2 and 6 weeks postoperative)
- Quality of Life (QoL)(2 and 6 weeks postoperative)
研究者
Jos M. A. Kuijlen
Dr. MD, PhD
University Medical Center Groningen