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CTRI Number  CTRI/2025/09/094200 [Registered on: 03/09/2025] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Diagnostic 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   A study in patients with lumbar spine problems comparing keyhole (minimally invasive) surgery and open surgery to see which causes less muscle damage and gives better recovery. 
Scientific Title of Study   A Prospective Comparative Study of Minimally Invasive and Open Transforaminal Lumbar Interbody Fusion Assessing Biochemical Markers Muscle Damage and Clinical Outcomes 
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   
Address  Department of Spine Services, Room No: 2, Indian Spinal Injuries Centre, Sector-C, Vasant Kunj

South West
DELHI
110077
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

South West
DELHI
110077
India 
Phone  9597600553  
Fax    
Email  vikas.spinesurgeon@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ganesh Kumar 
Designation  Research Fellow 
Affiliation   
Address  Department of Spine Services, Room No: 2, Indian Spinal Injuries Centre, Sector-C, Vasant Kunj

South West
DELHI
110077
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 
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
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: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Blood tests - namely ESR, CRP, CK-MB, and LDH will be collected as part of routine preoperative workup  All these blood tests will be collected, and the results of these tests will be compared between both groups (minimally invasive vs open) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients who had undergone one level open/minimally invasive transforminal Lumbar fusion surgery
 
 
ExclusionCriteria 
Details  More than 2 level surgery,
Patient who has undergone interbody fusion for infection, neoplasm, and deformity,
Patients who underwent uninstrumented fusion,
Age more than 60 years due to osteoporosis
Patients operated for tandem canal stenosis,
Ongoing psychiatric disease or under psychiatric care
Infection during followup
Muscular dystrophies,
Inflammatory diseases
Patients on antioxidants
Patients who underwent any kind of physiotherapy or manipulation 1 day prior to the surgery and
Neoplasm.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
ESR, CRP, LDH, CK MB

 
12 hrs before and after surgery
 
 
Secondary Outcome  
Outcome  TimePoints 
Preoperative VAS and ODI
 

12 hrs before and after surgery  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 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  
Minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is a surgical technique that appears to minimize iatrogenic paraspinal muscle injury thereby enhancing early recovery. In 2010, Villavicencio et al. compared the outcomes of 63 open and 76 MIS TLIF patients, and they reported comparable good clinical outcomes between the two groups, but with a higher neurological complication rate in the MIS group. In a meta-analysis by Wu et al. of 16 open TLIF studies consisting of 716 patients and eight MIS TLIF studies consisting of 312 patients, the authors reported similar fusion and complication rates in both groups. Likewise, multiple studies in the literature support the comparable long-term clinical outcomes between open and MI-TLIF patients.
Muscle injury is one of the points of interest that differentiates these two procedures. Dave et. al. showed that the mean reduction in lean muscle mass of multifidus muscle was greater in open TLIF compared to MIS-TLIF. However, Min et. al. at 1-year follow-up showed that there was less change in fat infiltration percentage and cross-sectional area in the MI-TLIF but there was no significant difference between the two groups. Although percutaneous pedicle screw fixation had positive effects on postoperative trunk muscle performance, clinical outcomes were not significantly different in areas of pain score, JOA score, and patient’s opinion regarding the outcome of the surgery as concluded by Kim and his colleagues. All the above studies evaluated the muscle damage using postoperative MRI imaging at different time intervals. The muscle damage that has been quantified using late postoperative MRI will be biased because of different rehabilitation protocols and variability between individuals, which is unavoidable. However, no study has evaluated or compared the biochemical muscle damage between the open and MI-TLIF groups. We hypothesize that muscle damage in minimally invasive techniques, using retractors through small incisions causes an increase in surrounding muscle pressure in the immediate postoperative period and hence the increased muscle damage compared to the open TLIF procedure.
 
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