Trials / Enrolling By Invitation
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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Endoscopic Foraminotomy Surgery | Endoscopic 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.