Analysis of Pedicle Screw Accuracy to Plan Using Medtronic Mazor Robotic System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total deviation (mm) from the pre-planned screw entry point
研究概览
简要总结
The purpose of the study is to assess screw deviation from pre-planned trajectory using the Mazor X robotic system in patients undergoing posterior thoracolumbar arthrodesis procedures between T2-S1.
详细描述
This trial will prospectively evaluate screw deviation from pre-planned trajectory using the standard of care Mazor X robotic system. Patients undergoing posterior thoracolumbar arthrodesis procedures utilizing pedicle screw instrumentation at previously uninstrumented levels for degenerative conditions, spinal deformity, spinal infection, trauma, or neoplastic processes between T2-S1 will be asked to participate in this prospective cohort study.
This single centered study will enroll up to 50 patients to achieve a total number of 250 screws for assessment. Subjects will be followed till discharge following surgery. All subjects enrolled in the study will be recruited from a pool of subjects eligible for posterior thoracolumbar arthrodesis surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Degenerative conditions, spinal deformity, spinal infection, traumatic injuries, or neoplastic processes between T2-S1 necessitating placement of pedicle screw instrumentation.
- •Surgery performed at The Ohio State University Wexner Medical Center (OSUWMC) via one of the study investigators
排除标准
- •Current or previous spinal tumor
- •Severe co-morbidities (e.g., heart, respiratory, or renal disease)
- •Concurrent involvement in another investigational drug or device study that could confound study data
- •Subjects who are pregnant
- •Subjects who do not speak English Relative Exclusion Criteria
- •Prior pedicle screw instrumentation at that level (i.e. prior L4-5 instrumentation, now undergoing an L4-S1 fusion, only new S1 screw accuracy would be evaluated in this patient)
研究组 & 干预措施
Arm 1
Single Arm. All participants undergoing posterior thoracolumbar arthrodesis procedures betweenT2-S1 in which preplanning is done using the Mazor X robotic system.
干预措施: Pedicle screw instrumentation using Mazor X robotic system (Device)
结局指标
主要结局
Total deviation (mm) from the pre-planned screw entry point
时间窗: study completion average 2years
Total deviation (mm) from the pre-planned screw entry point includes: deviation in angle of insertion in the axial plane (degrees), and deviation in angle of insertion in the sagittal plane (degrees) from an O-arm spin after screw placement.
次要结局
- Accuracy assessment for degree of pedicle breach(6 weeks post surgery)
研究者
Andrew Grossbach
Assistant Clinical Professor Residency Program Director Deformity and Robotic Spinal Fellowship Director
Ohio State University