Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
研究概览
地位
详细说明
Study Objective:
The study objective is to demonstrate via retrospective data review the relative value of two lumbar fusion procedures: transsacral lumbar interbody fusion and the transforaminal lumbar interbody fusion when used in conjunction with bilateral supplemental screw fixation as an adjunct to fusion. Subject candidates are those who had required fusion at L5-S1 where this was the only lumbar level treated for spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD).
Consecutive subjects who were treated with the transsacral lumbar interbody fusion or transforaminal lumbar interbody fusion procedure at least 1 year (- 2 months) prior to the date the data is collected will be evaluated.
Study Design, Endpoints:
Primary Endpoint:
Safety: Incidence of reported adverse events, including those requiring medical intervention, by 3 months post-operative.
Secondary Endpoints:
Health Economic: Operative measures, including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge, as applicable.
Health Economic: Comparative hospital data (from time of admission through time of discharge)
Clinical Effectiveness: A decrease in back pain compared to baseline at 3 months (+/-2 weeks) as measured by Visual Analog Scale (VAS).
Clinical Effectiveness: A decrease in disability compared to baseline at 3 months (+/-2 weeks) as measured by the Oswestry Disability Index (ODI).
Study Design, Enrollment:
Approximately 200 subjects will be enrolled in this study, 100 subjects who have been treated with transsacral lumbar interbody fusion and 100 subjects who have been treated with transforaminal lumbar interbody fusion.
Study Design, Analyses:
The retrospective clinical evaluation will collect and compare results for the procedure transsacral lumbar interbody fusion versus transforaminal lumbar interbody fusion as defined by the primary and secondary endpoints.
研究类型
注册 (预期的)
联系人和位置
学习地点
-
-
California
-
Fullerton、California、美国、92835
- St. Joseph Heritage Healthcare
-
-
Michigan
-
Waterford、Michigan、美国、48328
- Michigan Spine Institute
-
-
Ohio
-
Cleveland、Ohio、美国、44106
- University Hospitals Case Medical Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Adult aged 18 years or older
- Male or Female subject that had previously received transsacral single-level procedure when used in conjunction with bilateral pedicle screw fixation or TLIF single-level procedure with bilateral supplemental screw fixation (e.g. pedicle screws, anterior devices with screw anchoring, anterior lumber plates) as an adjunct to fusion at L5-S1 to treat spinal stenosis, spondylolithesis or degenerative disc disease (DDD)
- Subject that was treated no less than 1 year (-2 months) prior to this evaluation with a transsacral or TLIF procedure by participating surgeons
Exclusion Criteria:
- Subject had history of previous back operations at the time of the index procedure
- Subject had extraspinal cause of back pain or sciatica at the time of the index procedure
- Severe scoliosis in the lumbar region
- Subject was or is currently involved in active litigation
- Subject that had a diagnosis and received a transsacral or TLIF procedure at L5-S1 levels and did not require treatment at any other lumbar levels at the time of surgery.
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
---|
Transsacral lumbar interbody fusion
|
Transforaminal lumbar interbody fusion
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Safety
大体时间:3 months post-operative
|
Incidence of reported adverse events, including those requiring medical intervention.
|
3 months post-operative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Health Economic
大体时间:Up to 3 months post-operative
|
Operative measures including the direct and surrogate measurement of estimated blood loss, anesthesia time, transfusions, length of surgery and time to hospital discharge. Comparative hospital data |
Up to 3 months post-operative
|
Clinical Effectiveness
大体时间:3 months post-operative
|
A decrease in back pain compared to baseline at 3 months as measured by Visual Analog Scale A decrease in disability compared to baseline at 3 months as measure by the Oswestry Disability Index
|
3 months post-operative
|
合作者和调查者
调查人员
- 研究主任:Peter Whang, MD、Yale School of Medicine
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.