FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045400 [Registered on: 12/09/2022] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Single Arm Study 
Public Title of Study   Study to observe long time result after neck vertebrae disc replacement surgery. 
Scientific Title of Study   Long term clinical and radiological out-comes of cervical disc arthroplasty at a tertiary level spine center: A retrospective cohort analysis. 
Trial Acronym  RetroCDA 
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

Ahmadabad
GUJARAT
380006
India 
Phone  09825019913  
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

Ahmadabad
GUJARAT
380006
India 
Phone  09825019913  
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

Ahmadabad
GUJARAT
380006
India 
Phone  09825019913  
Fax  07926408174  
Email  brd_172@yahoo.com  
 
Source of Monetary or Material Support  
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 
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 Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 Ahmadabad GUJARAT
Ahmadabad
GUJARAT 		 09825019913
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  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1 All patients with degenerative cervical discopathy

2 All patients at one or more levels of the cervical spine leading to chronic and disabling radiculopathy, spondylotic and discogenic myelopathy, or both, resistant to well-conducted medical treatment

3 All patients operated by one of five board certified spine surgeon at Stavya Spine Institute and Research Center, since 2009 will be included in the study. 
 
ExclusionCriteria 
Details  1 Patients in which enough data can’t be retrieved from the medical records in this duration.

2 Patients who are lost to follow up

3 Patients with metabolic bone disease, congenital deformity, infection, neoplasia,

4 Previous cervical spine surgery at index level 
 
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 cervical disc arthroplasty at our institute   2009 at our institute and assess long-term clinical and radiological outcome over time. 
 
Secondary Outcome  
Outcome  TimePoints 
Statistical and accessory noninvasive information which will be collected as found additionally of importance.  2009 at our institute and assess long-term clinical and radiological outcome over time. 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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  

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. After failure of conservative treatment in patients with cervicaldegenerative disc disease, anterior cervical discectomyand fusion (ACDF) was the traditional standard surgicalprocedure.ACDF typically relieves painsignificantly, but elimination of motion at the index level, adjacent level degeneration and pseudoarthrosis remains a procedure specific complication.Cervical disc arthroplasty is aviable alternative to ACDF for the treatment of single-level cervical spine disease. A theoretical advantage of CDA is the capacity to preserve physiological range of motion (ROM) and index level, thereby potentially reducing adjacent level stresses and degeneration.

 
Close