Evaluation of the PediGuard™ for Pedicle Screw Insertion
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 108
- 试验地点
- 12
- 主要终点
- At least 90% of screws placed with the PediGuard™ will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan).
研究概览
简要总结
The aim of the study is to determine the relative effectiveness of the PediGuardTM , a device manufactured by SpineVision, Inc, for placement of a pedicle screw pilot (drill) hole and for reducing pedicle screw breaches during thoracic and lumbar pedicle screw fixation of the spine.
Hypothesis #1 The PediGuardTM will be more accurate for pedicle screw placement as compared to other standard manual techniques of similar size of pedicle screw insertion. At least 90% of screws placed with the PediGuardTM will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan). In contrast, only 80% of screws using manual placement will be positioned correctly in the pedicle.
Hypothesis #2 The PediGuardTM will not be inferior to fluoroscopic techniques for pedicle screw insertion. Both techniques will achieve at least 90% accuracy in the placement of pedicle screws.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary spinal fusion with pedicle screw fixation of the spine anywhere from T1to S1
- •Subjects must be skeletally mature as defined by closed growth plates on wrist via radiographs
- •Written informed consent and assent (assent for adolescents)
排除标准
- •Pedicle screw insertion by image guided techniques, including Fluoronav
- •Diagnoses associated with diminished bone mineral density such as osteogenesis imperfecta, severe osteopenia, neurofibromatosis
- •Severe senile osteoporosis (> 2 standard deviations below the norm)
- •Women who are pregnant
- •Children with open growth plates
- •Previously fused spinal levels
- •Unwillingness to sign written informed consent and assent.
结局指标
主要结局
At least 90% of screws placed with the PediGuard™ will be positioned correctly in the pedicle (defined as less than 2 mm breach by CT scan).
时间窗: Post-op CT prior to discharge
次要结局
未报告次要终点