| 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
|
|
|
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
|
|
|
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
|
|
|
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. |