About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression
Procedure/SurgeryThe 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
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Visual analog scale of leg pain
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
Visual analog scale of back pain
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
Modified Macnab criteria
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
Operative time
Operative time that using in each intervention start from when patient's skin is cut and stop when it is closed. Measure in minute
Sponsors and contacts
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