NCT07139938招募中不适用
Multicenter Study of Spontaneous Correction of Sagittal Imbalance After Isolated Decompression Surgery Without Corrective Fusion Procedure for Lumbar Spinal Stenosis
N.N. Priorov National Medical Research Center of Traumatology and Orthopedics6 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2025年10月6日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 165
- 试验地点
- 6
- 主要终点
- Change from baseline in lumbar balance parameters
研究概览
简要总结
Sagittal spinal imbalance may be caused by orthopedic problems, compression of the neural structures of the spinal canal, and pain syndrome (functional imbalance). Sagittal imbalance in combination with appropriate clinical symptoms may require surgical correction of the spine with fixation. However, in some cases, patients experience spontaneous correction of sagittal balance after isolated decompression without any correction or fusion. Therefore, it is necessary to clarify whether isolated decompression may cause spontaneous correction of sagittal imbalance in patients with degenerative lumbar stenosis.
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. Age 45 and over;
- •2. Radicular leg pain and/or neurogenic claudication with/without back pain, caused by single- or multi-level degenerative lumbar stenosis with/without spodylolisthesis, confirmed by MRI;
- •3. Planned isolated decompression of the spinal canal without implantation of any devices;
- •4. Symptoms persisting for at least 3 months prior to surgery;
- •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.
- •Non-Inclusion Criteria:
- •1. Prior any lumbar surgery;
- •2. Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.);
- •3. Degenerative scoliosis > 20 degrees;
- •4. Any contraindication or inability to undergo baseline and/or follow up MRI or X-ray as required per protocol;
- •5. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;
排除标准
- •1. Performed intraoperative discotomy;
- •2. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)
研究组 & 干预措施
Cohort
Other
Isolated lumbar decompression
干预措施: Isolated lumbar decomression (Procedure)
结局指标
主要结局
Change from baseline in lumbar balance parameters
时间窗: 3 months postoperatively
To observe the change from baseline in sagittal vertical axis by full body X-Ray, in mm
次要结局
- Change from baseline in lumbar balance parameters(3 months and 12 months postoperatively)
- Change in the cross-sectional area of the dural sac, mm2(3 months after surgery)
- Change from baseline in Oswestry Disability Index(3 months and 12 months postoperatively)
- 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 Neuropathic Pain 4 Questions(2 weeks (or at day of hospital discharge), 3 months, 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 months postoperatively)
- Change from baseline in posture alignment(2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively)
- Adverse Events(during study, an average of 12 months)
- Change from baseline in lumbar balance parameters(3 months and 12 months postoperatively)
- Change in the cross-sectional area of the dural sac, mm2(3 months after surgery)
- Change from baseline in Oswestry Disability Index(3 months and 12 months postoperatively)
- 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 Neuropathic Pain 4 Questions(2 weeks (or at day of hospital discharge), 3 months, 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 months postoperatively)
- Change from baseline in posture alignment(2 weeks (or at day of hospital discharge), 3 months, 12 months postoperatively)
- Adverse Events(during study, an average of 12 months)
研究者
研究点 (6)
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