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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  
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 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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M953||Acquired deformity of neck,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

 
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