Comparative Outcomes of Conventional TLIF With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery
NCT ID: NCT06685575
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
52 participants
INTERVENTIONAL
2024-11-01
2026-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery
standard surgery for foraminal stenosis
No interventions assigned to this group
Endoscopic Foraminotomy Surgery
The new type of surgery to treat lumbar foraminal stenosis which does not lead to instability of the spine
Endoscopic Foraminotomy Surgery
Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis
Interventions
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Endoscopic Foraminotomy Surgery
Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
80 Years
ALL
No
Sponsors
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Queen Savang Vadhana Memorial Hospital, Thailand
OTHER
Responsible Party
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Locations
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Tanyasinee Soonthornthum
Chon Buri, Changwat Chon Buri, Thailand
Countries
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Other Identifiers
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020/2567
Identifier Type: -
Identifier Source: org_study_id
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