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CTRI Number  CTRI/2025/12/099440 [Registered on: 18/12/2025] Trial Registered Prospectively
Last Modified On: 16/12/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Single Arm Study 
Public Title of Study   Changes in Spinal Canal Size and Patient Recovery After Lumbar Spine Surgery: A Prospective Study 
Scientific Title of Study   Prospective evaluation of spinal canal remodeling and clinical recovery after MIS-TLIF and open TLIF: Correlation of clinical and functional outcome with improvement in spinal canal diameter 
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  2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmadabad
GUJARAT
380006
India 
Phone  09825019913  
Fax    
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  2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali

GUJARAT
380006
India 
Phone  09825019913  
Fax    
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  2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali

GUJARAT
380006
India 
Phone  09825019913  
Fax    
Email  brd_172@yahoo.com  
 
Source of Monetary or Material Support  
NIL. 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , 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  2nd floor , Research Department , Stavya Spine Hospital and Research institute , Near Nagri Hospital , Mithakhali , Ellisbridge , Ahmedabad - 380006
Ahmadabad
GUJARAT 		 09825019913

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: M480||Spinal stenosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL.  NIL. 
Intervention  NIL.  NIL. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Radiologically confirmed degenerative lumbar spondylolisthesis with moderate-to-severe central canal stenosis.
2. Planned transforaminal lumbar interbody fusion (minimally invasive or open).
3. Single-level or multilevel fusion (two or more levels as clinically indicated; no upper limit).
4. Willing and able to provide consent and comply with postoperative follow-up.
 
 
ExclusionCriteria 
Details  1. History of prior lumbar instrumentation or decompression at the index level.
2. Presence of lumbar spine trauma, infection, neoplasm, or major spinal deformity (e.g., scoliosis greater than 20° Cobb angle).
3. Contraindication to magnetic resonance imaging (e.g., pacemaker, metallic implant incompatible with MRI).
4. Patient refusal to participate or inability/unwillingness to complete scheduled follow-up evaluations.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To quantify changes in back and leg pain (10-cm Visual Analogue Scale) and disability (Oswestry Disability Index) from baseline to the immediate postoperative period, postoperative day 1, postoperative day 2, and at 3, 6, and 12 months.
To measure radiological changes on MRI including dural sac cross sectional area and spinal canal cross sectional area, at baseline, 6 months, and 12 months.
To correlate radiologic improvement, particularly change in dural sac cross sectional area, with clinical and functional recovery measured by the Visual Analogue Scale and the Oswestry Disability Index at matched time points.
 		 All enrolled patients will be prospectively evaluated at baseline (Day 0, date of surgery) and followed up at 3, 6 and 12 months postoperatively for serial clinical, functional, and radiological assessments 
 
Secondary Outcome  
Outcome  TimePoints 
NIL.  NIL. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   29/12/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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  

The study will include consecutive adult patients (Greater than 18 years) diagnosed with degenerative lumbar spondylolisthesis and moderate-to-severe central canal stenosis on MRI, whose surgeons have already planned surgery using either MIS-TLIF or open TLIF. Consecutive enrolment during a 12-month window will reduce selection bias and reflect real-world practice.

Each patient will be followed for 12 months after surgery, allowing analysis of early recovery, radiological canal remodeling, and postoperative complications. All surgeries will be performed at a single centre by experienced surgeons using standardized operative steps (decompression, discectomy, cage insertion, and pedicle-screw fixation), ensuring uniformity of technique so that any differences observed later can be attributed mainly to the type of surgical approach rather than surgeon variability.

 
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