NCT00810433已完成不适用
A Clinical Safety and Feasibility Study of the GO-LIF® Approach
Mazor Robotics20 个研究点 分布在 2 个国家目标入组 10 人开始时间: 2009年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 20
- 主要终点
- The number, severity and causality of intra-operative and post-operative complications, with particular attention to nerve root irritation or injury.
研究概览
简要总结
The purpose of this study is to collect data regarding the safety and feasibility of the GO-LIF procedure for spinal fixation and stabilization, in conjunction with conventional approaches for interbody lumbar fusion. This is in order to allow for evidence-based comparison to pedicle-screw-based techniques as described in the literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18-80 years of age.
- •The capability to comprehend the nature and rationale of the study and to consent to participating in the study.
- •Unequivocal medical indication for the fixation surgery of a single motion segment of the lumbar spine.
- •Correct coronal profile of the lumbar spine. An asymmetric collapse of the disk space in the coronal plane between the vertebral bodies envisioned for instrumentation is by itself not an exclusion criterion.
- •Or any of criteria below:
- •Patients with Grade II or Grade III spondylolisthesis in the sagittal plane with preserved or normal sagittal alignment requiring single-level instrumented interbody fusion from L1 to S
- •(Not excluding patient with a need to decompression)
- •Patients must have normal alignment of the spine in the coronal view.
- •The interbody fusion approach may be TLIF or PLIF or ALIF or other, as clinically indicated.
- •The procedure may be combined with a Micro-decompression and/or Micro-discectomy and/or direct or indirect decompression and/or laminectomy or laminotomy and/or other procedures, as clinically indicated - as long as such procedures do not compromise the structural integrity of the pedicles of the inferior vertebra or the vertebral body of either vertebra of the levels involved..
- •Patient is 18 years or more
- •Patient is willing and able to comply with study requirements
排除标准
- •Lumbar hyperlordosis > 70° between the end plate of the lumbar vertebral body 1 and the end plate of the sacral vertebral body
- •Deformities of the vertebral bodies envisioned for instrumentation or the sacrum.
- •Spondylolisthesis > grade 2 acc. to Meyerding.
- •Scoliosis and other deformities in the coronal plane.
- •Fractures of the vertebrae envisioned for instrumentation.
- •Osteoporosis or osteopenia (see below for examination criteria).
- •Therapy with systemic corticosteroids or immunosuppressants.
- •Bone metabolism diseases, such as osteomalacia or Paget's disease.
- •Post inflammatory instability of the vertebral spine.
- •State after radiation therapy of the relevant vertebral spine region.
- •Current Marcoumar or heparin therapy for more than 6 months at the time of operation.
- •Malignant diseases with or without bone metastases.
- •Immunologic-inflammatory diseases (e.g., rheumatoid arthritis).
- •Diabetes mellitus.
- •Infectious diseases.
结局指标
主要结局
The number, severity and causality of intra-operative and post-operative complications, with particular attention to nerve root irritation or injury.
时间窗: prior to discharge from hospital
Number of significant cortical breaches (>4mm), as evidenced by visual examination of a post-operative CT scan.
时间窗: Preferably prior to discharge from hospital, and no later than 1 month post-op
The number of procedures that were not completed, and the reasons and causality for non-completions.
时间窗: Immediately post-op.
次要结局
- Plain AP, Lateral and flexion-extension radiographs. The radiographs will be examined for: • Evidence of bridging trabecular bone between the involved motion segments • Translational motion <3mm; and •Angular motion <5 degrees.(3, 6 and 12 months post-op.)
- Healthcare Outcomes: the visual analogue pain scale (VAS), the Oswestry disability index (ODI) and Swiss Spinal Stenosis (SSS) Questionnaire.(pre-op; 3, 6 and 12 months post-op)
研究者
研究点 (20)
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