A Prospective Observational Cohort Study to Analyze the Etiology of Revision Lumbar Spine Surgery at a Tertiary Care Spine Institute with 6 months follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 385
- 试验地点
- 1
- 主要终点
- • VAS-BP
研究概览
简要总结
Low back pain is a highly prevalent condition. About 3 percent of low backache casesneed to be
treated operatively . Severe back pain and radiating pain or claudication which are resistant to
conservative management are usually selected for surgical management.
Due to the increased aging population and the people increasingly getting operated for back ache,
the number of revision surgeries are also rising. Early surgical failures might result from insufficient
decompression and preoperative lumbar instability with late recurrence of back or leg
problems due to acquired spinal instability or adjacent level degeneration
Revision surgery is usually required at the index or adjacent levels.Mostly, revision surgery is required at the index or
at adjacent levels. The rates for re operation after decompression without fusion for LSS are rather
consistently reported to be around 8–10% 2 to 4 years following surgery
A meta analysis study which reviewed fenestration surgeries showed an average re operation
rate of 7.58% ± 5.29% in 8.28 ± 6.26 years follow up as compared to laminectomy alone (12.70%
± 7.49%, 6.50 ± 2.12 years follow up) . Laminectomy with or without fusion showed are operation
rate of 11.22% ± 4.25% in 6.00 ± 2.60 years follow up period. The comparative results of
these studies were however not significant.
While recent studies were able to identify particular factors, such as obesity, smoking, or
fusion as decisive for the outcome of lumbar operations, the literature has not demonstrated yet
whether these factors influence re operation.
Revision lumbar decompression and extension of fixation is the gold standard for
fixationElderly patients requiring revision lumbar spine surgery are a difficult cohort to
treat.Studies have reported poor outcomes when compared to the primary lumbar surgeries.
The goal of this study is to identify the various causes of revision at our institute, and find the
short term outcome. This would help us to identify the factors which needs to assessed to predict
outcome of revision surgeries.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 10.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All the lumbar spine cases admitted for revision surgery cases previously operated for stenosis, spondylolisthesis, disc prolapse, infections.
- •cases previously operated by endoscopic spine surgery, MIS spine surgery, open spine surgery.
- •cases giving consent for surgery.
- •age group 18 and above.
排除标准
- •patients who are not willing to be a part of study.
- •Age below 18.
结局指标
主要结局
• VAS-BP
时间窗: Enrolled patients will be followed for 6 months and clinical outcome will | be taken at 6 months
• VAS-LP
时间窗: Enrolled patients will be followed for 6 months and clinical outcome will | be taken at 6 months
• ODI
时间窗: Enrolled patients will be followed for 6 months and clinical outcome will | be taken at 6 months
次要结局
- NA(NA)
研究者
Dr Bharat R Dave
Stavya Spine Hospital And Research Institute