Clinical trial NCT06685575: Comparative Outcomes of Conventional TLIF With Posterior Decompression Surgery Versus Endoscopic Foraminotomy Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Foraminal Stenosis
Keywords: Lumbar Foraminal Stenosis
endoscopic decompression surgery
Endoscopic Foraminotomy Surgery
TLIF in lumbar foraminal stenosis
stable lumbar foraminal stenosis
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry disability index (ODI) score post-operation at 12months
timeFrame: 12 months
Secondary outcomes:
measure: Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months
timeFrame: 6week, 3 months and 6 months
measure: visual analog scale (VAS) of pain both leg and back
timeFrame: 1day, 2 weeks, 6weeks, 3 months, 6 months and 12 months
measure: estimated blood loss (EBL)
timeFrame: perioperation
measure: operative time
timeFrame: perioperation
measure: length of hospital stay
timeFrame: from 3 days to 1 week
measure: time return to work
timeFrame: through the study completion, an average of 1 year
measure: postoperative complications
timeFrame: through the study completion, an average of 1 year
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Tanyasinee Soonthornthum
state: Chonburi
Study officials:
References: