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临床试验/CTRI/2025/09/094462
CTRI/2025/09/094462尚未招募不适用

A Comprehensive Clinico-radiological Classification System for Lumbar Adjacent Segment Degeneration after TLIF

Ganesh Kumar1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Demographic details

研究概览

简要总结

As the spine ages, degenerative changes tend to occur naturally, a progression that complicates attempts to determine whether adjacent segment degeneration (ASD) results from surgical fusion, natural history, or other causes. Many studies in the past support both hypotheses. Although no conclusive etiology exists for ASD, natural history seems to be an important factor. There are initial attempts at classifying ASD viz. by Hilibrand et. al., Louie et al., and Park et al. However, these classification did not withstand the test of time because all these classification systems were solely based on radiological findings. Further, an ideal classification system should be reproducible, valid, reliable, provide guidelines for appropriate treatment, indicate the likelihood of complications, and be of prognostic importance. The lack of a universally accepted classification system makes it difficult to compare and analyse the data emanating from different centres. This would form the basis

for uniform reporting of results.

Hence, the objective of our study is to develop a comprehensive clinico-radiological classification system for Lumbar ASD after lumbar TLIF procedures with internal validation of the classification.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Underwent one or two level TLIF (from L1-S1) No adjacent segment changes in preoperative MRI or X-ray More than 5 years follow up.

排除标准

  • Patient who has undergone interbody fusion for infection, neoplasm, and deformity, Patients who underwent un-instrumented fusion No bony union at the index level during follow-up Patients operated for tandem canal stenosis Ongoing psychiatric disease (or under psychiatric care) Infection during follow-up Inflammatory diseases (Spondyloarthropathies).

结局指标

主要结局

Demographic details

时间窗: All these parameters will be recorded only once at their recent visit to the OPD. Which is at any point in time after 5 years from the date of surgery.

Clinical features

时间窗: All these parameters will be recorded only once at their recent visit to the OPD. Which is at any point in time after 5 years from the date of surgery.

radiological features

时间窗: All these parameters will be recorded only once at their recent visit to the OPD. Which is at any point in time after 5 years from the date of surgery.

次要结局

未报告次要终点

研究者

发起方
Ganesh Kumar
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

Ganesh Kumar

Spine surgery resident

研究点 (1)

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