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NCT Number: NCT06749314

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

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.

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Key information

Conditions

Degenerative Lumbar Spondylolisthesis Bone Diseases Lumbar Degenerative Disease Lumbar Spinal Stenosis Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Savang Nadhana Memorial Hospital

Chon Buri, 20110, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Other names: LE-ULBD, endoscopic decompression

Primary outcomes

  1. Oswestry Disability Index score

    Time frame: 1 year; Preoperative and post-operative at 12 months

    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

Secondary outcomes

  1. Visual analog scale of leg pain

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

    Pain score of leg pain from 1-10 determined by measuring in millimeters from the left hand end of the line to the point that the patient marks

  2. Visual analog scale of back pain

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

    Pain score of back pain from 1-10 determined by measuring in millimeters from the left hand end of the line to the point that the patient marks

  3. Modified Macnab criteria

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

    The Modified MacNab criteria are a set of guidelines used to assess the outcomes of spinal surgery, particularly in evaluating the effectiveness of procedures like discectomy or spinal fusion

  4. Operative time

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

    Operative time that using in each intervention start from when patient's skin is cut and stop when it is closed. Measure in minute

  5. Length of hospital stay

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

    Total days that the patients had been admitted to discharge

  6. Amount of blood loss

    Time frame: 1 day; Start from the skin's is cut through surgery period and postoperative until the drain bottle was removed.

    Total blood loss during surgery and postoperative measuring from visual estimation, gravimetric method, suction bottle and drainage bottle after surgery.

  7. Radiographic outcomes: lumbar slip percentage

    Time frame: 1 year; Preoperative and post-operative at 0,6 and 12 months

    Comparing lumbar slip percentage which calculated by measuring the displacement of the upper vertebral body relative to the lower vertebral body on a lateral radiograph preoperative and postoperative at each time point by:

    • Draw a line along the posterior border of the lower vertebral body
    • Draw a line perpendicular to the first line at the top of the lower vertebral body
    • Draw a line along the posterior border of the upper vertebral body
    • Calculate the percentage of the anterior translation of the upper vertebral body relative to the width of the lower vertebral body.

  8. Radiographic outcomes: Slip angle

    Time frame: 1 year; Preoperative and post-operative at 0,6,12 months

    The lumbar slip angle in spondylolisthesis is measured by drawing lines on a lateral X-ray and measuring the angle between them:

    • Extend a line along the anterior border of the upper vertebral body spondylolisthesis level
    • Draw a line along the posterior border of the lower vertebra spondylolisthesis level
    • Draw a line perpendicular to the posterior aspect of the first lower vertebra
    • Measure the angle between the line perpendicular to the first lower vertebra and a line parallel to the inferior end plate of upper vertebra A slip angle greater than 45 degrees is associated with a higher risk of instability, slip progression, and post-op pseudo-arthrosis.

  9. Radiographic outcomes: lumbar lordosis degree

    Time frame: 1 year; Preoperative and post-operative at 0,6,12 months

    The lumbar lordosis angle in spondylolisthesis is measured in degree by drawing lines on an X-ray film and calculating the angle formed by their intersection:

    • Draw a line tangent to the superior endplate of the first lumbar vertebra (L1)
    • Draw a line tangent to the inferior endplate of the fifth lumbar vertebra (L5)
    • Draw a perpendicular line to each tangent
    • The angle formed by the intersection of the two perpendicular lines is the lumbar lordosis angle

Study contacts

Contact information is provided by the study sponsor or research team.

Khanatip Jitpakdee, M.D.

CONTACT

[email protected]

+660812582050

Sirawit Wachirasakulchai, M.D.

CONTACT

[email protected]

+660859721082

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study title

Comparison of Endoscopic Lumbar Decompression and Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion (MIS-TLIF) for Degenerative Lumbar Spondylolisthesis: A Randomized Controlled Study

Acronym: MIS-TLIF

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 27, 2024
Registry last updated
Apr 22, 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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