Comparative Outcomes of Conventional TLIF With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery (TLIF)

Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study

Comparative Outcomes of Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis An Ambi-directional Cohort Study

Study Overview

• Status: Enrolling by invitation
• Conditions: Foraminal Stenosis
• Intervention / Treatment: Procedure: Endoscopic Foraminotomy Surgery

Detailed Description

Backgrounds :

Lumbar foraminal stenosis is a condition in which a spinal nerve is entrapped in a narrow lumbar foramen in degenerative lumbar spinal disorders. The gold standard treatment of this condition has not been proposed yet. Several different techniques for this problem has been described, including foraminotomy, facetectomy, partial pediculectomy, fusion, and distraction instrumentation.Nowadays, due to the great advancement of the technology in endoscopy expanded the indication of endoscopic decompression from the central canal to the extraforaminal zone, Which was difficult to gain access from the mere microscope.

Objectives :

To compare outcomes between posterior decompression With conventional transforaminal lumbar interbody fusion (TLIF) and full-endoscopic foraminoplasty (FELF) in stable lumbar foraminal Stenosis

Methods :

This is an ambi-directional cohort study, In retrospective part conducted from JAN2019-JAN2024 in Queen Savang Vadhana Memorial Hospital and the prospective part conducted from AUG2024 - JUNE 2025, Thailand. 60 patients presented with stable lumbar foraminal stenosis were divided into posterior decompression with conventional transforaminal lumbar interbody fusion (TLIF) group ( N=30) and full-endoscopic lumbar foraminoplasty (FELF) group (N=30). Demographic data and pre-perioperative parameters were analyzed. For TLIF group , Standard procedure had been performed.

Posterior decompression, pedicle screws and interbody cage ( Mont blanc, Spineway, France) insertion under image intensifier ( BV Pulsera,Philips).For endoscopic foraminoplasty , uniportal stenoscope ( Vertebris ,Riwospine ) was used to perform endoscopic decompressive surgery. Post-operative outcome , for instance , Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) were recorded at preoperative, post-op day1, 3 month, 6 month and 1 year respectively. Other parameters such as estimated blood loss (EBL), length of hospital stay and post- operative complications were also recorded

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chonburi
    • Chon Buri, Chonburi, Thailand, 20110
      • Tanyasinee Soonthornthum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 30-80
• Persist radiculopathy and sciatica pain
• Patient that was diagnosed Stable lumbar foraminal stenosis
• Failed conservative for at least 6 months
• Patients who willing to join the study

Exclusion Criteria:

• Patients with unstable lumbar foraminal stenosis
• Patient with spine infection or tumor or fracture
• Patient with BMD less than -2.5 or osteopenia
• Patient with inflammatory joint diseases who on steroids
• Patient who has undergo with surgery that inserted metals in back
• Unable to answer questionnaires
• Cannot tolerate surgery due to severe medical comorbidities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery; standard surgery for foraminal stenosis
Experimental: Endoscopic Foraminotomy Surgery; The new type of surgery to treat lumbar foraminal stenosis which does not lead to instability of the spine	Procedure: Endoscopic Foraminotomy Surgery; Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry disability index (ODI) score post-operation at 12months	Oswestry disability index (ODI) questionnaire at 12 months postoperative. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Minimal clinical difference has been evaluated across numerous types of spinal surgery, and has been shown to vary significantly.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months	Oswestry disability index (ODI) questionnaire at 6week, 3 months and 6 months. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Minimal clinical difference has been evaluated across numerous types of spinal surgery, and has been shown to vary significantly	6week, 3 months and 6 months
visual analog scale (VAS) of pain both leg and back	visual analog scale (VAS) of pain.A Visual Analogue Scale (VAS) score is interpreted by measuring the distance from the "no pain" end of a 100-mm line to a mark made by the patient to indicate their pain level. A higher score indicates greater pain intensity.	1day, 2 weeks, 6weeks, 3 months, 6 months and 12 months
estimated blood loss (EBL)	intraoperative estimated blood loss (EBL) measure in milliliter. estimated blood loss is a reliable predictor of actual blood loss during orthopedic procedures.	perioperation
operative time	operative time measure in minutes, usually 60-90 minutes	perioperation
length of hospital stay	length of hospital stay	from 3 days to 1 week
time return to work	time return to work	through the study completion, an average of 1 year
postoperative complications	postoperative complications	through the study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Lumbar Foraminal Stenosis; endoscopic decompression surgery; Endoscopic Foraminotomy Surgery; TLIF in lumbar foraminal stenosis; stable lumbar foraminal stenosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 020/2567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data was save inform of microsoft excel spreadsheet and SPSS file

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No