CTRI/2017/10/010221已完成不适用
A retrospective analysis of clinical and radiological outcome in Recurrent Disc Prolapse.
Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年6月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1 ODI and VAS Scores
研究概览
简要总结
This study is a retrospective analysis of 100 patients who have undergone surgery for recurrence of Lumbar Disc Prolapse.
Patients who met all inclusion/exclusion criteria will be enrolled in the study.
Patients will be evaluated for clinical outcome by recording Oswestry Disability Index (ODI) Score and Visual Analogue Scores (VAS) and
radiological outcome using X-Rays of L.S.Spine at the final follow up , after primary surgery by lumbar fusion at our center.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age : 25 – 85 yrs , Male or Female 2.Single level Lumbosacral fusion L4-5 or L5-S1 operated by conventional posterior approach for recurrent disc.
- •3.Psychosocially, mentally and physically able to fully comply with this protocol including adhering to completing forms and other study procedures.
- •4.Personally signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
排除标准
- •1.Redo discectomy 2.Lumbar infection.
- •3.Lumbar laminectomy.
结局指标
主要结局
1 ODI and VAS Scores
时间窗: 12 - 18 months
2 X-Rays of L S Spine AP and
时间窗: 12 - 18 months
Lateral
时间窗: 12 - 18 months
次要结局
- 1 ODI and VAS Scores(2 X-Rays of L S Spine AP and)
研究者
研究点 (1)
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