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

NCT06749314 | Not Yet Recruiting DMC

• 1 other identifier: 024/2567
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Lumbar Spondylolisthesis; Lumbar Degenerative Disease; Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index score

  The Oswestry Disability Index (ODI) is a patient-completed questionnaire made up of 10 questions, each with six statements that are scored from 0 to 5. The questions cover a range of activities, including pain intensity, personal care, walking, sleeping, social life, and travel. The ODI score ranges from 0% to 100%, with higher scores indicating more severe disability: 0-20%: Mild disability 20-40%: Moderate disability 40-60%: Severe disability 60-80%: Disabling 80-100%: Bedridden or functional impairment

  1 year; Preoperative and post-operative at 12 months

Secondary Outcomes (9)

• Visual analog scale of leg pain

  1 year; Preoperative and post-operative at 1,3,6 and 12 months

• Visual analog scale of back pain

  1 year; Preoperative and post-operative at 1,3,6 and 12 months

• Modified Macnab criteria

  1 year; Preoperative and post-operative at 1,3,6 and 12 months

• Operative time

  1 day; From patient's skin is cut, through each intervention surgery completion (minute) when the skin is closed

• Length of hospital stay

  1 year; The date from the patients had been admitted to discharge

Study Arms (2)

Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression

EXPERIMENTAL

using endoscopic decompression for treatment

Procedure: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression

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

NO INTERVENTION

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

Interventions

Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression 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

Also known as: LE-ULBD, endoscopic decompression

Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang Nadhana Memorial Hospital

Chon Buri, 20110, Thailand

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Sirawit Wachirasakulchai, M.D.

CONTACT

+660859721082; sirawit.wac@gmail.com

Khanatip Jitpakdee, M.D.

CONTACT

+660812582050; pooh_maru116@hotmail.com

Study Design

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

Model Details: The participants were randomized into two group with computer generated block-of-four randomization with allocation 1:1 into two groups. The control group recieved MIS TLIF while the experimental group recieved endoscopic decompression.

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 27, 2024
• Study Start: May 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)