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CTRI Number  CTRI/2025/09/094462 [Registered on: 09/09/2025] Trial Registered Prospectively
Last Modified On: 03/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Developing a simple system to classify spine problems that occur in patients after lumbar fusion surgery, using clinical symptoms and scan findings 
Scientific Title of Study   A Comprehensive Clinico-radiological Classification System for Lumbar Adjacent Segment Degeneration after TLIF 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ganesh Kumar 
Designation  Research Fellow 
Affiliation  Spine surgery resident 
Address  Department of Spine Services, Room No: 2, Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, New Delhi
Department of Spine Services, Room No: 2, Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, New Delhi
South West
DELHI
110070
India 
Phone  9597600553  
Fax    
Email  sgk.ortho@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vikas Tandon 
Designation  Guide of the Project 
Affiliation  Chief of Spine Services 
Address  Department of Spine Services, Room No: 2, Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9868886228  
Fax    
Email  vikas.spinesurgeon@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ganesh Kumar 
Designation  Research Fellow 
Affiliation  Indian Spinal Injuries Centre 
Address  Department of Spine Services, Room No: 2, Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, New Delhi

South West
DELHI
110070
India 
Phone  9597600553  
Fax    
Email  sgk.ortho@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Ganesh Kumar 
Address  Department of Spine Services, Room No: 2, Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, New Delhi-110070 
Type of Sponsor  Other [Self funded] 
 
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 Ganesh Kumar  Indian Spinal Injuries Centre  Department of Spine Services, Room No: 2, Indian Spinal Injuries Centre, Sector-C, Vasant Kunj, New Delhi
South West
DELHI 
9597600553

sgk.ortho@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INDIAN SPINAL INJURIES CENTRE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M479||Spondylosis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Underwent one or two level TLIF (from L1-S1)
No adjacent segment changes in preoperative MRI or X-ray
More than 5 years follow up
 
 
ExclusionCriteria 
Details  Patient who has undergone interbody fusion for infection, neoplasm, and
deformity,

Patients who underwent un-instrumented fusion

No bony union at the index level during follow-up

Patients operated for tandem canal stenosis

Ongoing psychiatric disease (or under psychiatric care)

Infection during follow-up

Inflammatory diseases (Spondyloarthropathies) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Demographic details
Clinical features
radiological features 
All these parameters will be recorded only once at their recent visit to the OPD. Which is at any point in time after 5 years from the date of surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/10/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
As the spine ages, degenerative changes tend to occur naturally, a progression that complicates attempts to determine whether adjacent segment degeneration (ASD) results from surgical fusion, natural history, or other causes. Many studies in the past support both hypotheses. Although no conclusive etiology exists for ASD, natural history seems to be an important factor. There are initial attempts at classifying ASD viz. by Hilibrand et. al., Louie et al., and Park et al. However, these classification did not withstand the test of time because all these classification systems were solely based on radiological findings. Further, an ideal classification system should be reproducible, valid, reliable, provide guidelines for appropriate treatment, indicate the likelihood of complications, and be of prognostic importance. The lack of a universally accepted classification system makes it difficult to compare and analyse the data emanating from different centres. This would form the basis
for uniform reporting of results.
Hence, the objective of our study is to develop a comprehensive clinico-radiological classification system for Lumbar ASD after lumbar TLIF procedures with internal validation of the classification.
 
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