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Enrolling by Invitation

NCT Number: NCT06685575

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

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Key information

Conditions

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanyasinee Soonthornthum

Chon Buri, Changwat Chon Buri, 20110, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Foraminotomy Surgery

Procedure

Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis

Primary outcomes

  1. Oswestry disability index (ODI) score post-operation at 12months

    Time frame: 12 months

    Oswestry disability index (ODI) questionnaire at 12 months postoperative. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Minimal clinical difference has been evaluated across numerous types of spinal surgery, and has been shown to vary significantly.

Secondary outcomes

  1. Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months

    Time frame: 6week, 3 months and 6 months

    Oswestry disability index (ODI) questionnaire at 6week, 3 months and 6 months. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound. Minimal clinical difference has been evaluated across numerous types of spinal surgery, and has been shown to vary significantly

  2. visual analog scale (VAS) of pain both leg and back

    Time frame: 1day, 2 weeks, 6weeks, 3 months, 6 months and 12 months

    visual analog scale (VAS) of pain.A Visual Analogue Scale (VAS) score is interpreted by measuring the distance from the "no pain" end of a 100-mm line to a mark made by the patient to indicate their pain level. A higher score indicates greater pain intensity.

  3. estimated blood loss (EBL)

    Time frame: perioperation

    intraoperative estimated blood loss (EBL) measure in milliliter. estimated blood loss is a reliable predictor of actual blood loss during orthopedic procedures.

  4. operative time

    Time frame: perioperation

    operative time measure in minutes, usually 60-90 minutes

  5. length of hospital stay

    Time frame: from 3 days to 1 week

    length of hospital stay

  6. time return to work

    Time frame: through the study completion, an average of 1 year

    time return to work

  7. postoperative complications

    Time frame: through the study completion, an average of 1 year

    postoperative complications

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study 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

Acronym: TLIF

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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