跳至主要内容
临床试验/CTRI/2022/02/040133
CTRI/2022/02/040133招募中不适用

“A retrospective analysis of demographic, clinical and postoperative data of all cervical spine patients operated at a spine center - Our experience of 18 yearsâ€

Stavya Spine Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Single time analysis of clinical out comes all the operated cervical spine patients at our institute

研究概览

简要总结

As the mean age of population increase, the percentage ofpopulation with cervical spine disorders invariably increases. Cervical spinesurgery improves outcomes in select patients with cervical spine pathology.With newer technologies and surgical techniques, there has been a significantimprovement in cervical spine patient outcomes in the recent years. Mostoperative cervical pathologies can be treated by anterior [ACDF, ACCF, TDR,etc.] or by posterior approach [Laminectomy with or without instrumentation, OCfusion, Post. C1, C2 fixation, etc.]. Clinical decision making andevidence-based medicine makes up a huge part in management of cervical spinecases, however generating high quality data in spine surgery is plagued withunique challenges.

 Currentlymost of the clinical research in spine consider a follow-up in a range of 2-5years. Long term effects of surgical intervention on the spine invariably leadto altered biomechanics and kinematics in the spine3. Problems likeadjacent segment degeneration (ASD) are a known entity to occur in asignificant number of cases on a longer follow-up. Longer term studies might begiving a better insight in the effects that a surgery might have had on thepatients

 Anotherdimension which is rarely taken into consideration in studies is the learningcurve any institution invariably goes through in its process of maturation.Similar surgical candidates operated on by the same surgeon 10 years apartmight have significant differences in outcomes, due to evolution of surgeoncapabilities, resources and patient management protocols over time.

 We havebeen privileged enough to cater to large volumes of spine patients in ourcenter, and it has also enabled us to implement some enabling technologies,which include the use of intraoperative CT scans, navigation, use of ultrasonicbone scalpel, intraoperative neuromonitoring and latest improvements in surgicallyimplanted materials just to name a few. Apart from improvements in OTcapabilities, we were also able to develop resources in data management, likeelectronic medical records (EMR) and picture archiving and communication system(PACS). That along with meticulous protocols of data entry has enabled us tohave access to vast amounts of clinical patient data.

 Properanalysis of this data can provide us with insights not only of patient outcomesbut also of learning curves over time, unique complication and ways of managingthem, and how enabling technologies might have improved surgical outcomes.

 Objective of the study:

 Our goal for this project is to do a retrospective analysisof all the patients operated for cervical spine at our institute and assessoutcomes and various other parameters over time.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • •All cervical spine cases operated at Stavya Spine Institute and Research Center, from a peri-od between 2003-2020 will be included in the study.

排除标准

  • •Patients in which enough data can’t be retrieved from the medical records in this duration/ There is significant attrition of data.

结局指标

主要结局

Single time analysis of clinical out comes all the operated cervical spine patients at our institute

时间窗: 2 years

次要结局

  • Demographic data , per operative & post operative data(2 years)

研究者

发起方
Stavya Spine Hospital and Research Institute
申办方类型
Research institution and hospital

研究点 (1)

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