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

N/AEnrolling By InvitationNCT06685575

Queen Savang Vadhana Memorial Hospital, Thailand52 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Foraminal Stenosis

Interventions

Endoscopic Foraminotomy SurgeryPROCEDURE

Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Tanyasinee Soonthornthum

Chon Buri, Changwat Chon Buri, Thailand

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: perioperation

operative time

operative time measure in minutes, usually 60-90 minutes

Time frame: perioperation

Data from ClinicalTrials.gov

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