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CTRI Number  CTRI/2024/01/061187 [Registered on: 08/01/2024] Trial Registered Prospectively
Last Modified On: 10/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   Unveiling the Causes of Revision Lumbar Spine Surgery: Insights from a Prospective Observational Cohort Study at a Leading Tertiary Care Spine Institute" 
Scientific Title of Study   A Prospective Observational Cohort Study to Analyse the Etiology of Revision Lumbar Spine Surgery at a Tertiary Care Spine Institute. 
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  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  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  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  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  07926408174  
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  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  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  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details 
cases previously operated for stenosis, spondylolisthesis, disc prolapse, infections.
cases previously operated by endoscopic spine surgery, MIS spine surgery, open spine
surgery.
cases giving consent for surgery.
Age group 18 and above 
 
ExclusionCriteria 
Details  patients who are not willing to be a part of study.
Age below 18.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This is a study to find the causes of revision surgery hence no outcomes will be measured.  No scheduling requirements for this study as the study is about causes only 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   13/01/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Low back pain is a highly prevalent condition. About 3 percent of low backache cases need to
be treated operatively . Severe back pain and radiating pain or claudicating which are resistant
to conservative management are usually selected for surgical management.
Due to the increased aging population and the people increasingly getting operated for back
ache, the number of revision surgeries are also rising. Early surgical failures might result from
insufficient decompression and preoperative lumbar instability, or infection with late recurrence
of back or leg problems due to acquired spinal instability or adjacent level degeneration
 Revision surgery is usually required at the index or adjacent levels. Mostly, revision surgery
is required at the index or at adjacent levels. The rates for re operation after decompression
without fusion for LSS are rather consistently reported to be around 8–10% 2 to 4 years
following surgery.
A meta analysis study which reviewed fenestration surgeries showed an average re operation
rate of 7.58% ± 5.29% in 8.28 ± 6.26 years follow up as compared to laminectomy alone
(12.70% ± 7.49%, 6.50 ± 2.12 years follow up). Laminectomy with or without fusion
showed a re operation rate of 11.22% ± 4.25% in 6.00 ± 2.60 years follow up period. The
comparative results of these studies were however not significant .
While recent studies were able to identify particular factors, such as obesity, smoking, or fusion
as decisive for the outcome of lumbar operations, the literature has not demonstrated yet
whether these factors influence re operation.
Revision lumbar decompression and extension of fixation is the gold standard for fixation.Elderly patients requiring revision lumbar spine surgery are a difficult cohort to
treat. Studies have reported poor outcomes when compared to the primary lumbar surgeries.
The goal of this study is to identify the various causes of revision at our institute.
 
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