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CTRI Number  CTRI/2025/03/082755 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 26/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare BETWEEN CONVENTIONAL AND MINIMAL INVASIVE Spine SURGERY in terms of which has better outcome and also has less days of hospital stay and intraoperative blood loss and early rehabilitation 
Scientific Title of Study   COMPARITIVE ANALYSIS OF FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF OPEN TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) AND MIS (MINIMALLY INVASIVE) TLIF: An OPEN LABEL PARALLEL RANDOMISED CONTROLLED STUDY 
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 Saurabh Sah 
Designation  Associate Professor 
Affiliation  AIIMS NAGPUR 
Address  Room no 220 , Department of orthopedics ,AIIMS NAGPUR , SUMTHANA , DAHEGAON , NEAR IIM NAGPUR

Nagpur
MAHARASHTRA
441108
India 
Phone  9423637719  
Fax    
Email  saurabh.sah@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saurabh Sah 
Designation  Associate Professor 
Affiliation  AIIMS NAGPUR 
Address  Room no 220 , Department of orthopedics, AIIMS NAGPUR , SUMTHANA , DAHEGAON , NEAR IIM NAGPUR

Nagpur
MAHARASHTRA
441108
India 
Phone  9423637719  
Fax    
Email  saurabh.sah@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanshu 
Designation  Junior Resident 
Affiliation  AIIMS NAGPUR 
Address  Room no 217 , Department of Orthopedics, AIIMS NAGPUR , SUMTHANA , DAHEGAON , NEAR IIM NAGPUR

Nagpur
MAHARASHTRA
441108
India 
Phone  9325560721  
Fax    
Email  priyanshu296@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Jyotirao Phule Jan Arogya Yojana Room no 40 Ground floor IPD building , MJPJAY OFFICE , AIIMS NAGPUR , Sumthana , Dahegaon , Maharashtra 441108 
 
Primary Sponsor  
Name  Mahatma Jyotirao Phule Jan Arogya Yojana 
Address  AIIMS NAGPUR , SUMTHANA, DAHEGAON, NAGPUR , MAHARASHTRA , 441108 
Type of Sponsor  Government funding agency 
 
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 Priyanshu  AIIMS NAGPUR OPD  Room no 217 , Second floor , OPD building ,Department of Orthopedics, AIIMS NAGPUR , SUMTHANA , DAHEGAON , NEAR IIM NAGPUR
Nagpur
MAHARASHTRA 		 09325560721

priyanshu296@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS NAGPUR Department of Pharmacology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M431||Spondylolisthesis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MIS ( MINIMALLY INVASIVE ) TLIF  - A small paramedian incision of about 3 cm would be made on the side from which cage insertion is planned. - Sequential dilators splitting the muscles would be passed over a guide wire and a tubular retractor of diameter 25 mm of appropriate length would be placed and connected to the table. - Hemilaminectomy and inferior facet excision would be done. - Discectomy and end plate preparation would be done. - With under cutting of the spinous process, the opposite side lateral recess decompression would be done by going over the top of the dural tube. - Locally harvested bone graft and cage placement would be same as in open TLIF. - Ipsilateral pedicle screws will be placed through the tubular retractor and the opposite side pedicle screws would be placed percutaneously under C- arm guidance and pre contoured rods tightened over the screws.  
Comparator Agent  OPEN TLIF ( TRANSFORAMINAL LUMBAR INTERBODY FUSION )  - After the level is marked, midline incision, paraspinal muscles will be dissected subperiosteally and retracted bilaterally. - The bilateral pedicle screws would be inserted under fluoroscopy control. - Laminectomy with bilateral lateral recess decompression would be done. - Inferior facet excision on the more symptomatic side or the left side will be excised. - Discectomy and end plate preparation would be done. - Appropriate cage size would be ascertained. - Locally harvested bone would be filled in the disc space anteriorly and then a PEEK bullet cage with bone graft of the determined size would put into the disc space. - Cage position would be checked by visual inspection and by fluoroscopy. - Reduction screws if required would be used for listhesis reduction. - Pre contoured rods will be tightened over the screws. - Wound will be washed and closed in layers and no suction would be kept.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Adult with Age more than 18 years patients with single level degenerative/ lytic/ dysplastic lumbar listhesis -Meyer ding classification Grade 1 -3 with canal stenosis with or without neurodeficit with claudication/ radiculopathy with instability and not responding to conservative treatment.
- Single level degenerative stenosis with claudication/ radiculopathy with congenital bony canal stenosis such that adequate decompression may entail iatrogenic instability and not responding to conservative treatment.
-Willingness to participate in the study and forgo any other concomitant treatment modality with written informed consent
 
 
ExclusionCriteria 
Details  - Post traumatic spondylolisthesis
-High grade (4 and above) dysplastic listhesis
-Pathological fractures
- Prior spinal surgeries
- active infection
- malignancy
- Patients unfit for undergoing surgery
- severe osteoporosis
-Not willing to participate in the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the Functional and Radiological outcomes of Open TLIF (Transforaminal Lumbar Interbody Fusion) and MIS TLIF in adult patient  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To document & analyse complications, hospital stay, intraoperative blood loss in both the operative methods  6 months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 1 
Date of First Enrollment (India)   01/04/2025 
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="1"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyanshu296@gmail.com].

  6. For how long will this data be available start date provided 21-07-2026 and end date provided 02-01-2046?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Study will be conducted at Orthopedics department, AIIMS NAGPUR. Patients presenting to orthopedics OPD with backpain and lower limb radiculopathy/claudication not responding to conservative measures will be screened for exclusion and inclusion criterion as per study. The demographic data will be recorded in the case record sheet. The patient will be informed about the study and informed consent will be recorded in the standard format. The patients will be randomized to undergo surgery with either of the two methods (OPEN TLIF or MIS TLIF). It will be an open label study. The participants, as well as the investigator assessing the outcomes, will be aware of the group allotment . Visual Analog scale score for pain and Oswestry disability index will be documented preoperatively for all patients.  The patients will be randomized into 2 treatment groups. All patients would have done X rays Lumbar spine AP and Lat (Static and Dynamic views) and MRI Lumbosacral spine with whole spine screening for their diagnosis. Surgery will be performed under general anesthesia in prone position. In case of open TLIF the interbody cage will be inserted from the side which is more symptomatic and if both sides are equally symptomatic then from the left side.  Patients in both the groups would mobilize out of bed from post operative day 1 with lumbosacral belt support. Patients will be started with isometric back and abdominal exercises after 2 weeks. After 1-month patients will be asked to stop the use of belt. Any post operative neurological complication will be documented. The patients will be followed at 2 weeks, 1 month, 3 months and 6 months. All the patients will be assessed clinically and radiologically at all the follow-ups. The functional outcome will be assessed using the Visual Analog Scale and Oswestry Disability index at the each follow up. Radiologically assessment will be done using Anteroposterior and lateral X-rays. Fusion will be determined by using Bridwell Interbody fusion grading system in AP and lateral x-rays and time to fusion will be documented. Data will be entered in an MS Excel spreadsheet and analyzed using SPSS software. Categorical variables such as gender will be described as frequencies and percentages. Continuous variables such as age, and functional score measured through various indices will be summarized as mean and Standard deviation. The intraoperative time, Intraoperative blood loss, hospital stay and Visual Analog score for pain on follow up, number of complications arising with operative method and post-op reduction in hemoglobin values will be evaluated using Unpaired t test (given that these parameters are distributed normally). In case of non-normal distribution of the mentioned parameters, Mann-Whitney U test will be used. A p value of <0.05 will be considered significant.  
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