ISOVUE Contrast for Intraoperative Assessment of Discectomy Quality in TLIF: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Anteroposterior Plane Clearance
研究概览
简要总结
This study aimed to investigate a novel technique for intraoperative quantitative and qualitative feedback during discectomy and endplate preparation in TLIF.
详细描述
The purpose of this study was to introduce a novel surgical technique using ISOVUE-300M contrast dye for intraoperative visualization of discectomy progress and to test the value of this technique by comparing outcomes of two patient cohorts. The investigators hypothesize that the standard TLIF technique results in a surprisingly low percentage of effective disc preparation, even when performed by an experienced TLIF surgeon. Secondly, the investigators hypothesize that by using intraoperative visual feedback to guide a second discectomy pass that the extent of disc space preparation can be substantially improved compared to patients where visual feedback is not available. Lastly, the investigators aim to conduct a clinical outcomes analysis evaluating radiographic and complication outcomes. To the best of the authors' knowledge, this prospective study is the first to evaluate differences in disc space preparation using a novel contrast-based technique while also providing clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing open circumferential transforaminal lumbar interbody fusion or midline cortical TLIF for degenerative spondylolisthesis
排除标准
- •All not in the group above
研究组 & 干预措施
Observation
In the Observation group, after initial discectomy and endplate preparation, ISOVUE-300M contrast was administered into the disc space and orthogonal anterior-posterior and lateral radiographs were obtained. The case then proceeded with graft and cage insertion without additional disc excision or endplate work.
干预措施: ISOVUE 300 Observation (Procedure)
Feedback
In the Feedback group, the surgeon was permitted to utilize the ISOVUE imaging as a feedback mechanism to then re-prepare the disc space prior to final graft/cage insertion. An additional dose of ISOVUE-300M was administered into the disc space with repeat radiographs obtained prior to grafting/cage insertion to demonstrate the effect of the second pass of disc and cartilage removal.
干预措施: ISOVUE 300 Feedback (Procedure)
结局指标
主要结局
Anteroposterior Plane Clearance
时间窗: Immediately after Discectomy
Disc space clearance in the anteroposterior (AP) plane at the index level measured on oblique radiographs.
Mediolateral Plane Clearance
时间窗: Immediately after Discectomy/Excision Intraoperatively
Disc space clearance in the mediolateral (ML) plane as measured by oblique radiographs.
Visual Analog Scale
时间窗: First Postoperative Clinic Appointment (within first 6 weeks)
Visual Analog Scale survey assessing leg pain and back pain
次要结局
- Lumbar Lordosis(Immediately after Discectomy Intraoperatively)
- Pelvic Incidence(Immediately after Discectomy Intraoperatively)
- Disc Height(Immediately after Discectomy Intraoperatively)
- Oswestry Disability Index(First Postoperative Clinic Appointment (within first 6 weeks))
- Short Form Survey(First Postoperative Clinic Appointment (within first 6 weeks))