| CTRI Number |
CTRI/2025/12/098949 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative analysis of interbody fusion techniques |
|
Scientific Title of Study
|
Comparative Study of Oblique Lumbar interbody Fusion with Posterior Spinal Fusion (OLIF with PSF) vs Minimally Invasive Transforaminal interbody Fusion (MI-TLIF) with static cage vs Minimally Invasive Transforaminal interbody Fusion (MI-TLIF) with Expandable cage in Degenerative Spondylolisthesis |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shashank singh |
| Designation |
Fellow |
| Affiliation |
medanta- the medicity |
| Address |
6th floor OPD, Institute of neurosciences, Medanta The medicity, sector 38, Gurugram
Gurgaon HARYANA 122001 India |
| Phone |
8871702144 |
| Fax |
|
| Email |
ssbaghel4@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
shashank singh |
| Designation |
Fellow |
| Affiliation |
medanta- the medicity |
| Address |
6th floor OPD, Institute of neurosciences, Medanta The medicity, sector 38, Gurugram
HARYANA 122001 India |
| Phone |
8871702144 |
| Fax |
|
| Email |
ssbaghel4@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
shashank singh |
| Designation |
Fellow |
| Affiliation |
medanta- the medicity |
| Address |
6th floor OPD, Institute of neurosciences, Medanta The medicity, sector 38, Gurugram
HARYANA 122001 India |
| Phone |
8871702144 |
| Fax |
|
| Email |
ssbaghel4@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [Nil ] |
|
|
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 Shashank Singh Baghel |
Medanta The Medicity |
6th floor, Insitute of NEUROSCIENECES, MEDANTA- tHE MEDICITY Sector 38 Medanta The Medicity Hospital Gurgaon Haryana Gurgaon HARYANA |
8871702144
ssbaghel4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M431||Spondylolisthesis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 40 to 80 years
Radiologically confirmed degenerative spondylolisthesis
Patients who underwent or will undergo OLIF or TLIF or TLIF with expandable cage
Minimum follow up of 6 months available
|
|
| ExclusionCriteria |
| Details |
Traumatic or infectious or neoplastic spinal pathology
Revision spine surgeries
Severe osteoporosis T-score less –2.5
Active systemic infection or malignancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare clinical and radiological outcomes in patients undergoing OLIF, TLIF, and TLIF with expandable cage for degenerative spondylolisthesis.
|
0, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate perioperative parameters (operative time, blood loss, hospital stay).
To assess complication rates among the three groups.
To study radiological parameters like disc height, foraminal height, adjacent segment degeneration, and lumbar lordosis angle at various follow-up intervals.
|
0, 6 months |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
01/01/2026 |
| 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="0" Months="11" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 spondylolisthesis is a common cause of low back pain and radiculopathy, predominantly affecting the aging population. Surgical intervention is indicated when conservative management fails. Among the most frequently used interbody fusion techniques are transforaminal lumbar interbody fusion (TLIF), TLIF with expandable cage, and oblique lumbar interbody fusion (OLIF). Each method offers distinct advantages and limitations regarding biomechanical stability, indirect decompression, restoration of sagittal balance, and patient outcomes. TLIF has long been the gold standard for lumbar fusion due to its posterior access and high fusion rates. However, it may be associated with significant muscle disruption and less optimal restoration of disc height and alignment. OLIF, on the other hand, offers a minimally invasive lateral approach, avoiding the psoas muscle and the spinal canal, with the potential for better lordosis correction and disc height restoration, while minimizing neural injury risk. Recent innovations include the use of expandable cages in TLIF, designed to allow in situ height expansion, potentially enhancing disc height and lordosis restoration without increasing retraction-related complications. However, despite widespread clinical application, there is limited high-quality evidence directly comparing these three surgical techniques using both clinical and radiological metrics. Multiple studies have shown superior restoration of disc and foraminal height and lower complication rates with OLIF compared to traditional TLIF[i]. Others suggest that expandable cages may provide biomechanical advantages in TLIF without substantially altering complication profiles[ii] [iii]. However, comparisons across these modalities remain scarce and often limited by sample size, heterogeneity in pathology, or lack of long-term radiological follow-up[iv] [v]. Thus, this study aims to comprehensively evaluate and compare the clinical and radiological outcomes of OLIF, TLIF, and TLIF with expandable cage in a uniform pathology setting — degenerative spondylolisthesis — through a prospective study. |