Effectiveness of an Intraoperative Spine Measurement Tool and Outcomes Assessment From Its Use in Spinal Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of times the adjustment tool failed to represent the POF within a margin of 3 degrees
研究概览
简要总结
This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with intraoperatively achieving pre-planned alignment-related parameters to the patient's spine. The study will also collect outcomes data to determine if achievement of these spinal alignment-related parameters result in satisfactory outcomes and if it reduces the rate of secondary surgeries.
Objectives
Primary: To evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with achieving the surgeon's preplanned alignment-related parameters intraoperatively.
Secondary: To determine if there is a correlation between 1) achievement of preoperative planned alignment-related parameters intraoperatively, and 2) outcomes.
Hypothesis
The application of the intraoperative spinal measurement tool for patients undergoing spinal fusion surgery will improve the surgeon's ability to achieve pre-planned alignment-related parameters intraoperatively and doing so will provide improved outcomes.
详细描述
Patient reported outcomes data will be collected on two separate forms- the Oswestry Disability Index (ODI) and the SF-36. The ODI has been widely used since its development in 1980 and has been viewed as effective for measuring disability in daily living associated with low back pain4. The SF-36 is the most used patient reported outcomes measure used both generically as well as specifically for low back pain, and it consists of both a mental as well as physical assessment5. Study data will be compared to historical literature data.
The intraoperative spinal measurement system to be used is the Paradigm TM System by Proprio.
Patients will fill out ODI and SF-36 and will have a postoperative standing long x-ray or EOS at regular follow-up intervals (typically 6w, 3m, 6m, 12m, 24m).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Adult patients aged 18 years or older at the time of surgery
- •Type of Surgery: Consecutively scheduled patients where the measurement system will be used who will have thoracolumbosacral posterior spine surgery that includes spinal instrumentation and fusion and that consent to the study
排除标准
- •Patients treated for traumatic injury (penetrating injuries, etc.)
- •Incarcerated persons
- •Pregnant females
- •Any patient current in another trial for a new implant or technique
- •Non-Spine Related Surgeries: Patients who had surgeries for reasons other than spine-related conditions (even if they incidentally involved the spine)
- •Patients having additional surgery occurring concurrently with spine surgery
- •Patients ineligible for surgery
研究组 & 干预措施
Thoracolumbosacral posterior spine surgery using intraoperative measurement system
To evaluate the effectiveness of a novel intraoperative spinal measurement tool to assist the surgeon with achieving preoperatively planned alignment-related parameters during surgery. Patients may also be included when the surgeon uses another system or method for placement of the implants (i.e., other navigation system, robot, fluoroscopy, etc.) but also wants to utilize the measurement system. The data will be analyzed as a pool and stratified according to level and # of levels and other demographic and operative data to determine if there are differences.
干预措施: Intraoperative spinal measurement system (Device)
结局指标
主要结局
Number of times the adjustment tool failed to represent the POF within a margin of 3 degrees
时间窗: Pre-operative planned state (enrollment), Postoperative final state (12 months)
Effectiveness of the intraoperative spinal measurement tool will be assessed
次要结局
- Number of secondary surgeries(Enrollment to 24 months post-operatively)
- Patient Reported Outcomes as measured by the Oswestry Disability Index (ODI)(Enrollment to 24 months post-operatively)
- Patient Reported Outcomes as measured by the 36-Item Short Form Survey (SF-36)(Enrollment to 24 months post-operatively)