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CTRI Number  CTRI/2022/02/040133 [Registered on: 09/02/2022] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   An analysis of demographic, clinical and postoperative data of all cervical spine patients operated at a spine center - Our experience of 18 years” 
Scientific Title of Study   “A retrospective analysis of demographic, clinical and postoperative data of all cervical spine patients operated at a spine center - Our experience of 18 years” 
Trial Acronym  Retro18Cx 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bharat R Dave 
Designation  Director(Spine Surgeon) 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad
Ahmadabad
GUJARAT
380006
India 
Phone  9825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharat R Dave 
Designation  Director(Spine Surgeon) 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad

GUJARAT
380006
India 
Phone  9825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bharat R Dave 
Designation  Director(Spine Surgeon) 
Affiliation  Stavya Spine Hospital And Research Institute 
Address  Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad

GUJARAT
380006
India 
Phone  9825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Source of Monetary or Material Support  
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad Gujarat 380006 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bharat R Dave  Stavya Spine Hospital & Research Institute  No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006
Ahmadabad
GUJARAT 
9825019913
07926408174
brd_172@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Stavya Spine hospital & Research Institute IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  Patients in which enough data can’t be retrieved from the medical records in this duration/ There is significant attrition of data 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Single time analysis of clinical out comes all the operated cervical spine patients at our institute   2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Demographic data , per operative & post operative data  2 years 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2022 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

 

Currently most of the clinical research in spine consider a follow-up in a range of 2-5 years. Long term effects of surgical intervention on the spine invariably lead to altered biomechanics and kinematics in the spine3. Problems like adjacent segment degeneration (ASD) are a known entity to occur in a significant number of cases on a longer follow-up. Longer term studies might be giving a better insight in the effects that a surgery might have had on the patients

 

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

 

We have been privileged enough to cater to large volumes of spine patients in our center, and it has also enabled us to implement some enabling technologies, which include the use of intraoperative CT scans, navigation, use of ultrasonic bone scalpel, intraoperative neuromonitoring and latest improvements in surgically implanted materials just to name a few. Apart from improvements in OT capabilities, we were also able to develop resources in data management, like electronic medical records (EMR) and picture archiving and communication system (PACS). That along with meticulous protocols of data entry has enabled us to have access to vast amounts of clinical patient data.

 

Proper analysis of this data can provide us with insights not only of patient outcomes but also of learning curves over time, unique complication and ways of managing them, and how enabling technologies might have improved surgical outcomes.

 

Objective of the study:

 

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

 
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