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Enrolling by invitation NCT06685575

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

No phase Interventional Foraminal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic Foraminotomy Surgery.
Who it may be relevant to
Registry conditions: Foraminal Stenosis. Basic parameters: 30 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

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

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

Interventions

  • Procedure Endoscopic Foraminotomy Surgery
    Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis

Primary outcome measures

  • Oswestry disability index (ODI) score post-operation at 12months [Time frame: 12 months]
Secondary outcome measures (7)
  • Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months [Time frame: 6week, 3 months and 6 months]
  • visual analog scale (VAS) of pain both leg and back [Time frame: 1day, 2 weeks, 6weeks, 3 months, 6 months and 12 months]
  • estimated blood loss (EBL) [Time frame: perioperation]
  • operative time [Time frame: perioperation]
  • length of hospital stay [Time frame: from 3 days to 1 week]
  • time return to work [Time frame: through the study completion, an average of 1 year]
  • postoperative complications [Time frame: through the study completion, an average of 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Thailand · 1 center
  • Tanyasinee Soonthornthum — Chon Buri

Identifiers

NCT: NCT06685575 · 020/2567

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗