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

Not Applicable

• Conditions: Foraminal Stenosis

• Registration Number: NCT06685575
• Lead Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

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

This is an Ambi-directional Cohort Study that studied postoperative outcomes in the population who has back pain and radiculopathy from stable lumbar foraminal stenosis and divided into two groups, one group under conventional Transforaminal Lumbar Interbody Fusion with Posterior Decompression Surgery and the other group under endoscopic foraminotomy surgery. This study was done at Queen Savang Vadhana Memorial Hospital from August 2024 to June 2025. The participants were divided into two groups as mentioned under frequency matching to minimize bias, each group had 26 cases, total number of participants was 52 cases. The control group went under conventional Transforaminal Lumbar Interbody Fusion with Posterior Decompression Surgery and the other group went under endoscopic foraminotomy surgery.

This study hypothesizes that functional outcome postoperatively in patients with stable lumbar foraminal stenosis who underwent endoscopic foraminotomy surgery is non-inferior to that in patients with stable lumbar foraminal stenosis who underwent conventional Transforaminal Lumbar Interbody Fusion with Posterior Decompression Surgery.

The power in this study is 0.8 and the p-value is \<0.05

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-01
• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12
• Primary Completion: 2025-09-30
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Oswestry disability index (ODI) score post-operation at 12months	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 Outcome Measures

Name	Time	Method
Oswestry disability index (ODI) score post-operation at 6week, 3 months and 6 months	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
visual analog scale (VAS) of pain both leg and back	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.
estimated blood loss (EBL)	perioperation	intraoperative estimated blood loss (EBL) measure in milliliter. estimated blood loss is a reliable predictor of actual blood loss during orthopedic procedures.
operative time	perioperation	operative time measure in minutes, usually 60-90 minutes
length of hospital stay	from 3 days to 1 week	length of hospital stay
time return to work	through the study completion, an average of 1 year	time return to work
postoperative complications	through the study completion, an average of 1 year	postoperative complications

Trial Locations

Locations (1)

Tanyasinee Soonthornthum; 🇹🇭 Chon Buri, Chonburi, Thailand