Comparison of Endoscopic Lumbar Decompression and Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Degenerative Lumbar Spondylolisthesis

NCT ID: NCT06749314

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-05-31

Brief Summary

Comparing the functional and radiographic outcomes in surgical treatment in failed conservative treatment, single-level low grade degenerative lumbar spondylolisthesis between Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion, which is conventional treatment recently, and Endoscopic Lumbar Decompression, which is minimal invasive in symptomatic treatment.

Detailed Description

This was a randomized controlled trial in patient with single-level low grade degenerative lumbar spondylolisthesis with failed conservatives treatment, by comparing two group of surgical intervention between Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) and Endoscopic lumbar decompression using functional outcomes.

The participants were randomized into two groups with 33 cases each group (Total = 66) by using computer generated program with block of four randomization with allocation ratio 1:1. The control group received conventional treatment which is Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion while the experimental group received endoscopic lumbar decompression. Using ODI score as primary outcome. Data were analyzed using chi-square test for categorical data (eg, sex, symptoms of weakness and numbness, level of spondylolisthesis) and unpaired T-test for continuous data (eg. VAS score, ODI, slippage percentage, lumbar lordosis degree, slip angle, op time) which considered significant difference of the outcomes when p < 0.05 with a power of 80%. Consider endoscopic decompression is non-inferiority to MIS-TLIF when upper limit of the one-sided 95%CI for the differences in ODI means is less than margin (12.8 points) If the results show that endoscopic decompression is non-inferiority to MIS TLIF, endoscopic lumbar decompression may be a choice of treatments giving benefit of minimal invasive surgery and avoid interbody fusion complication such as pseudoarthrosis, adjacent problems and operative blood loss

Conditions

Degenerative Lumbar Spondylolisthesis; Lumbar Degenerative Disease; Lumbar Spinal Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression

using endoscopic decompression for treatment

Group Type: EXPERIMENTAL

Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression

Intervention Type: PROCEDURE

The LE-ULBD: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression is a single portal through lamina with instrument to decompression both side of the spinal canal, giving strength of preserve facet joint, preserve spinal musculature, mitigate the risk of adjacent fusion and lesser bleeding

MIS-TLIF: Minimal Invasive Surgery - Transforaminal Lumbar interbody Fusion

Using conventional treatment, minimal invasive decompression with interbody fusion surgery for treatment in control groups

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression

The LE-ULBD: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression is a single portal through lamina with instrument to decompression both side of the spinal canal, giving strength of preserve facet joint, preserve spinal musculature, mitigate the risk of adjacent fusion and lesser bleeding

Intervention Type: PROCEDURE

Other Intervention Names

LE-ULBD; endoscopic decompression

Eligibility Criteria

Inclusion Criteria

• Single level lumbar degenerative spondylolisthesis (Meyerding Grading Grade I or II).
• Failed conservative treatment for at least 3 months.
• No instability evidence of levels of lesion (Consideration from translation more than 5 mm or angulation change more than 10 degree in flexion and extension L-S plain films ).
• Able to follow up for at least 12 months.
• Patient who vorantarily agree to participate in research.

Exclusion Criteria

• Patients with severe foraminal stenosis diagnosed by MRI.
• Patients who have previously undergone lumbar spine surgery (revision surgery).
• Patients with other abnormalities in the lumbar spine, such as infection, tumors, or fractures.
• Patients who cannot undergo surgery due to underlying conditions or who cannot maintain the prone position for extended periods.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen Savang Vadhana Memorial Hospital, Thailand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Queen Savang Nadhana Memorial Hospital

Chon Buri, , Thailand

Countries

Thailand

Central Contacts

Sirawit Wachirasakulchai, M.D.

Role: CONTACT

sirawit.wac@gmail.com

+660859721082

Khanatip Jitpakdee, M.D.

Role: CONTACT

pooh_maru116@hotmail.com

+660812582050

Other Identifiers

024/2567

Identifier Type: -

Identifier Source: org_study_id