跳至主要内容
临床试验/CTRI/2024/01/061187
CTRI/2024/01/061187招募中不适用

A Prospective Observational Cohort Study to Analyse the Etiology of Revision Lumbar Spine Surgery at a Tertiary Care Spine Institute.

Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 385 人开始时间: 2024年1月13日最近更新:

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
This is a study to find the causes of revision surgery hence no outcomes will be measured.

研究概览

简要总结

Low back pain is a highly prevalent condition. About 3 percent of low backache cases need to

be treated operatively . Severe back pain and radiating pain or claudicating 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, or infection 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 a re 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 fixation.Elderly 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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 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

This is a study to find the causes of revision surgery hence no outcomes will be measured.

时间窗: No scheduling requirements for this study as the study is about causes only

次要结局

  • NA(NA)

研究者

发起方
Stavya Spine Hospital and Research Institute
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Bharat R Dave

Stavya Spine Hospital And Research Institute

研究点 (1)

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