CTRI Number |
CTRI/2022/09/045348 [Registered on: 08/09/2022] Trial Registered Prospectively |
Last Modified On: |
10/07/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Retrospective |
Study Design |
Single Arm Study |
Public Title of Study
|
Study to analyze long term result of neck spinal surgery at tertiary spine center in India |
Scientific Title of Study
|
Retrospective long term follow-up analysis of anterior cervical corpectomy and fusion in cervical myelopathy at tertiary level spine center in India |
Trial Acronym |
|
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 |
Principal Investigator and Spine Surgeon |
Affiliation |
Stavya Spine Hospital And Research Institute |
Address |
No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute
Ellisbridge Mithakhali Ahmedabad 380006
Ahmadabad
GUJARAT
380006
India No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute
Ellisbridge Mithakhali Ahmedabad 380006
Ahmadabad
GUJARAT
380006
India Ahmadabad GUJARAT 380006 India |
Phone |
09925248584 |
Fax |
07926408174 |
Email |
brd_172@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Bharat R Dave |
Designation |
Principal Investigator and Spine Surgeon |
Affiliation |
Stavya Spine Hospital And Research Institute |
Address |
No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute
Ellisbridge Mithakhali Ahmedabad 380006
Ahmadabad
GUJARAT
380006
India No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute
Ellisbridge Mithakhali Ahmedabad 380006
Ahmadabad
GUJARAT
380006
India Ahmadabad GUJARAT 380006 India |
Phone |
09925248584 |
Fax |
07926408174 |
Email |
brd_172@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Bharat R Dave |
Designation |
Principal Investigator and Spine Surgeon |
Affiliation |
Stavya Spine Hospital And Research Institute |
Address |
No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute
Ellisbridge Mithakhali Ahmedabad 380006
Ahmadabad
GUJARAT
380006
India No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute
Ellisbridge Mithakhali Ahmedabad 380006
Ahmadabad
GUJARAT
380006
India
GUJARAT 380006 India |
Phone |
09925248584 |
Fax |
07926408174 |
Email |
brd_172@yahoo.com |
|
Source of Monetary or Material Support
|
No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute
Ellisbridge Mithakhali Ahmedabad 380006
Ahmadabad
GUJARAT
380006
India |
|
Primary Sponsor
|
Name |
Stavya Spine Hospital and Research Institute |
Address |
No. 9 2nd floor Annexe Stavya Spine hospital and Research Institute
Ellisbridge Mithakhali Ahmedabad 380006
Ahmadabad
GUJARAT
380006
India |
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
380006
India 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: M953||Acquired deformity of neck, |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
90.00 Year(s) |
Gender |
Both |
Details |
patients who underwent anterior cervical corpectomy and fusion for degenerative cervical myelopathy at one or more levels of the cervical spine operated by one of five board certified spine surgeon at Stavya Spine Institute and Research Center since 2009 with minimum 2 years of follow up will be included in the study. |
|
ExclusionCriteria |
Details |
• Patients in which enough data can’t be retrieved from the medical records in this du-ration.
• Lost to follow up
• Neoplasm, infection cervical spine
• Previous cervical spine surgery
• Neurodegenerative diseases
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Single time analysis of all the patient who underwent anterior cervical corpectomy and fusion for cervical myelopathy at our institute. |
from 2009 at our institute with minimum follow up of 2 years. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Statistical and accessory noninvasive information which will be collected as found additionally of importance.
|
from 2009 at our institute with minimum follow up of 2 years. |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
12/09/2022 |
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
|
Cervical spondylotic myelopathy (CSM) is the most common
cause of spinal cord dysfunction in older persons1. With ageing as
the degenerative changes in the cervical spine sets intervertebral discs,
ligaments and connective tissue of the cervical vertebrae, can lead to
compression of the spinal cord, which results in myelopathy2. The
natural history of CSM is mixed and unpredictable. Patients with CSM may
present as a gradual decline in neurological function or in a progressive
setting with a long period of quiescence3. Surgical intervention has
been the mainstay for progressive CSM because conservative treatment had not
been proved to be effective in altering the natural course of this disease4.
The principal goal of surgical intervention is to achieve adequate expansion of
the canal diameter, thus providing the cord with adequate space to avoid static
or dynamic compression. Anterior approaches for the surgical treatment of CSM,
including anterior cervical discectomy and fusion (ACDF) and anterior cervical
corpectomy and fusion (ACCF), have been widely over the years5. ACCF
is an established treatment for cervical degenerative diseases, which offers
several advantages, including direct decompression of neural structures, proper
visualization of posterior osteophytes, ossified posterior longitudinal
ligament immediate stabilization of operated segments, solid fusion and
maintenance or restoration of normal cervical alignment6,7. The
short term outcomes of ACCF in CSM have
shown good outcome7.8, but relatively long term studies on ACCM for
treatment of CSM is scarce in literature. |