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