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CTRI Number  CTRI/2024/01/061208 [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
Modification(s)  		 Why Do Some People Need a Second Back Surgery? A 6-Month Check-Up Study 
Scientific Title of Study   A Prospective Observational Cohort Study to Analyze the Etiology of Revision Lumbar Spine Surgery at a Tertiary Care Spine Institute with 6 months follow-up 
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  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: M430||Spondylolysis,  
 
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 the lumbar spine cases admitted for revision surgery
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 
• VAS-BP
• VAS-LP
• ODI
 
Enrolled patients will be followed for 6 months and clinical outcome will
be taken at 6 months 
 
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 casesneed to be
treated operatively . Severe back pain and radiating pain or claudication 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  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 are 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
fixationElderly 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, and find the
short term outcome. This would help us to identify the factors which needs to assessed to predict
outcome of revision surgeries.
 
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