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CTRI Number  CTRI/2024/01/061235 [Registered on: 08/01/2024] 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   Unveiling the Results of Multiple Revision Surgeries in the Lumbar Spine: A Retrospective Analysis of Outcomes 
Scientific Title of Study   A retrospective analysis of outcomes in multiple revision surgeries in lumbar spine 
Trial Acronym  NIL 
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  Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India

Ahmadabad
GUJARAT
380006
India 
Phone  9825019913  
Fax    
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  Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India


GUJARAT
380006
India 
Phone  9825019913  
Fax    
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  Room No-9, 2nd floor Annexe , Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India


GUJARAT
380006
India 
Phone  9825019913  
Fax    
Email  brd_172@yahoo.com  
 
Source of Monetary or Material Support  
Room no. 9, second floor Annexe Department Research department Stavya Spine Hospital and Research Institute Ellisbridge,Mithakhali. 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Room no. 9, second floor Annexe,Department Research department. Stavya spine hospital and Research Institute,Ellisbridge,Mithakhali.Ahmadabad GUJARAT 
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  Room no. 9, second floor Annexe,Department Research department.Stavya spine hospital and Research Institute ,Ellisbridge,Mithakhali. Ahmadabad GUJARAT
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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All patients who have undergone more than one revision surgery for a degenerative lumbar spine dis-order will be included in the study 
 
ExclusionCriteria 
Details  Patients who do not comply with the inclusion criteria
Patients with inadequate follow up
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Cause for revision surgery.
Clinical improvement posts the procedure in terms of VAS and ODI scores.
Complications with revision procedures
 
The patients are followed at least for 2 years post the last surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/01/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

A few decades ago, spine surgery was only performed in a few specialized hospitals. These days, there are a lot of well-trained spine surgeons performing spine procedures. The increase in spine surgical procedures can be attributed to improvements in diagnostic assessment, anesthesiological support and surgical instrumentation 1-5. Spine surgery in general has become a more common, much safer and more efficient procedure. However, it has also become much more complex. Difficult cases that were previously advocated to be non-operatively treated have now started to be treated surgically. This increasing case load has resulted in significant technical improvements, but also brought about a substantial number of devastating failures and more complex revision surgeries. The major challenges for spine surgeons now are to consider patient satisfaction, social costs and the safety of the surgeries themselves. It was shown that 50% to 90% of the patients will substantially benefit from the surgery for lumbar spinal stenosis (LSS)6,7 . However, the outcome tends to deteriorate in the long term and some of the patients will suffer a certain period after the operation from return of their previous symptoms8 .In patients having adequate canal decompression due to spinal stenosis, a restenosis of the spinal canal can occur. The number of patients requiring reoperation is likely to increase with time9.

The following study aims to find the amount of cases undergoing multiple revision surgeries, the cause and outcomes of multiple revision surgeries and the complications associated with them.

 
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