| CTRI Number |
CTRI/2026/03/105500 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two surgical treatment for narrowing of the spine |
|
Scientific Title of Study
|
Outcomes of Decompression Alone versus Decompression With Fusion in Degenerative Lumber Spinal Stenosis |
| 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 Amit Yadav |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Orthopaedics, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7895317347 |
| Fax |
|
| Email |
accessamit31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sohael Khan |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Orthopaedics, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923455744 |
| Fax |
|
| Email |
drsohaelkhan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sohael Khan |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept. of Orthopaedics, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9923455744 |
| Fax |
|
| Email |
drsohaelkhan@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education And Research, Sawangi Meghe, Wardha, India ,442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Sawangi Meghe, Wardha, India ,442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Amit Yadav |
Acharya Vinoba Bhave Rural Hospital |
Dept. of Orthopaedics, Ground Floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA |
7895317347
accessamit31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Spinal decompression |
Cases of degenerative lumber spinal stenosis will be treated with decompression at the lumber level in old individuals |
| Comparator Agent |
Spinal decompression with fusion |
Patient with degenerative lumber canal stenosis will be treated with decompression with spinal spinal fusion |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing Decompression Alone Versus Decompression with Fusion in Degenerative Lumber Spinal Stenosis .
2.Patients who are willing to take part in study after informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patient’s refusal to participate in the study
2. Lumbar spine trauma
3. History of lumbar spine reoperation
4. Spinal or other infections
5. Primary or secondary spinal tumour
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study compares the outcomes of decompression alone versus decompression with fusion to determine whether routine fusion is justified in the absence of overt instability |
Assessment will be done at 4 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Degenerative lumbar spinal stenosis is a common
cause of chronic back pain and neurogenic claudication, often requiring
surgical intervention. Degenerative lumbar
spinal stenosis is also one of the most
common indications for spinal surgery in the aging population. This will be a randomized control trial which aims to evaluate the outcomes of decompression alone versus decompression with fusion in degenerative lumber spinal stenosis. Total 70 cases will be randomized and assessed to compare outcomes of these two techniques in AVBRH Wardha. |