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Enrolling By InvitationNCT06685575

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
Phase
N/A
Study type
Interventional
Enrollment
52 (estimated)
Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand · Academic / Other
Sex
All
Age
30 Years – 80 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREEndoscopic Foraminotomy SurgeryEndoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis

Timeline

Start date
2024-11-01
Primary completion
2025-09-30
Completion
2026-10-31
First posted
2024-11-12
Last updated
2025-06-13

Locations

1 site across 1 country: Thailand

Source: ClinicalTrials.gov record NCT06685575. Inclusion in this directory is not an endorsement.