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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06685575
Acronym
TLIF
Enrollment
52
Registered
2024-11-12
Start date
2024-11-01
Completion date
2026-10-31
Last updated
2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foraminal Stenosis

Keywords

Lumbar Foraminal Stenosis, endoscopic decompression surgery, Endoscopic Foraminotomy Surgery, TLIF in lumbar foraminal stenosis, stable lumbar foraminal stenosis

Brief summary

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

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

Interventions

PROCEDUREEndoscopic Foraminotomy Surgery

Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis

Sponsors

Queen Savang Vadhana Memorial Hospital, Thailand
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oswestry disability index (ODI) score post-operation at 12months12 monthsOswestry 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.

Secondary

MeasureTime frameDescription
visual analog scale (VAS) of pain both leg and back1day, 2 weeks, 6weeks, 3 months, 6 months and 12 monthsvisual 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.
estimated blood loss (EBL)perioperationintraoperative estimated blood loss (EBL) measure in milliliter. estimated blood loss is a reliable predictor of actual blood loss during orthopedic procedures.
operative timeperioperationoperative time measure in minutes, usually 60-90 minutes
Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months6week, 3 months and 6 monthsOswestry 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
time return to workthrough the study completion, an average of 1 yeartime return to work
postoperative complicationsthrough the study completion, an average of 1 yearpostoperative complications
length of hospital stayfrom 3 days to 1 weeklength of hospital stay

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026