| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
|
|
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. |