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

NCT06685575 | Enrolling By Invitation DMC

• 1 other identifier: 020/2567
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Foraminal Stenosis

Keywords

Lumbar Foraminal Stenosis; endoscopic decompression surgery; Endoscopic Foraminotomy Surgery; TLIF in lumbar foraminal stenosis; stable lumbar foraminal stenosis

Outcome Measures

Primary Outcomes (1)

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

  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.

  12 months

Secondary Outcomes (7)

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

  6week, 3 months and 6 months

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

  1day, 2 weeks, 6weeks, 3 months, 6 months and 12 months

• estimated blood loss (EBL)

  perioperation

• operative time

  perioperation

• length of hospital stay

  from 3 days to 1 week

Study Arms (2)

Conventional Transforaminal Lumbar Interbody Fusion With Posterior Decompression Surgery

NO INTERVENTION

standard surgery for foraminal stenosis

Endoscopic Foraminotomy Surgery

EXPERIMENTAL

The new type of surgery to treat lumbar foraminal stenosis which does not lead to instability of the spine

Procedure: Endoscopic Foraminotomy Surgery

Interventions

Endoscopic Foraminotomy Surgery PROCEDURE

Endoscopic Foraminotomy Surgery in Stable Lumbar Foraminal Stenosis

Endoscopic Foraminotomy Surgery

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Tanyasinee Soonthornthum

Chon Buri, Changwat Chon Buri, 20110, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: November 4, 2024
• First Posted: November 12, 2024
• Study Start: November 1, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)