Restoring Segmental Lordosis Via One Previous Posterior Approach After Failed Fusion at the Same Level for Degenerative Lumbar Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in lumbar balance parameters
研究概览
简要总结
The restoration of lumbar lordosis is mandatory during lumbar fusion surgery for degenerative disc disease, since not restoring lumbar lordosis adequately may adversely affect surgical outcomes and the patient's quality of life in the follow-up. Revision surgery to restore segmental lordosis at the level of previous spinal fusion is extremely difficult to do and its performance is usually inferior to that of primary surgery. Need to provide a surgical technique to restore segmental lordosis via a posterior approach, which is especially important after failed previous fusion at the same lumbar level.
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
- •1. Over 18 years' old;
- •2. Lumbar back pain with / without radicular leg pain (with / without neurological deficit) with / without neurogenic claudication, symptoms persisting for at least 3 months prior to surgery;
- •3. 1) Failed back lumbar fusion surgery at the same level or on an adjacent segment or 2) Symptomatic discopathy with loss of segmental lordosis at one of the levels L3-L4, L4-L5 or L5-S1, confirmed by MRI и Rg, with/without degenerative stenosis/spondylolisthesis
- •4. Need for a planned surgical procedure with a major extent of segmental lordosis restoration (more than 10°);
- •5. Given written informed consent;
- •6. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements
排除标准
- •1. Interbody implants previously placed via non-posterior approach at the level of surgery (which cannot be removed through the posterior approach);
- •2. Complete interbody fusion after previous surgery at the level of surgery;
- •3. HU values of lumbar body vertebrae less than 120 HU;
- •4. Any contraindication or inability to undergo baseline and/or follow up MRI, CT or X-ray as required per protocol;
- •5. Back or non-radicular pain of unknown etiology;
- •6. History or presence of any other major neurological disease or condition that may interfere with the study assessments;
- •7. Previous enrollment in this study, current enrollment or plans to be enrolled in another study (in parallel to this study).
研究组 & 干预措施
Cohort
All patients will undergo restoring segmental lordosis via one previous posterior approach after failed fusion at the same level.
干预措施: Restoring segmental lordosis at the lumbar spine (Procedure)
结局指标
主要结局
Change from baseline in lumbar balance parameters
时间窗: 2 weeks postoperatively (or at day of hospital discharge)
To observe the change from baseline in segmental lordosis at operated level by CT, in degrees
次要结局
- Change from baseline in Numeric Pain Rating Scale(2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively)
- Change from baseline in lumbar balance parameters(12 months postoperatively)
- Change from baseline in Oswestry Disability Index(2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively)
- Change from baseline in The Health Transition Item from SF-36(2 weeks (or at day of hospital discharge), 3 months, 12 and 12 months postoperatively)
- Adverse Events(during study, an average of 12 months)