Clinical trial NCT06749314: Comparison of Endoscopic Lumbar Decompression and Minimally Invasive Transforaminal Lumbar Interbody Fusion(MIS-TLIF) for Degenerative Lumbar Spondylolisthesis
Official title: Comparison of Endoscopic Lumbar Decompression and Minimal Invasive Surgery Transforaminal Lumbar Interbody Fusion (MIS-TLIF) for Degenerative Lumbar Spondylolisthesis: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Degenerative Lumbar Spondylolisthesis
Lumbar Degenerative Disease
Lumbar Spinal Stenosis
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Oswestry Disability Index score
timeFrame: 1 year; Preoperative and post-operative at 12 months
Secondary outcomes:
measure: Visual analog scale of leg pain
timeFrame: 1 year; Preoperative and post-operative at 1,3,6 and 12 months
measure: Visual analog scale of back pain
timeFrame: 1 year; Preoperative and post-operative at 1,3,6 and 12 months
measure: Modified Macnab criteria
timeFrame: 1 year; Preoperative and post-operative at 1,3,6 and 12 months
measure: Operative time
timeFrame: 1 day; From patient's skin is cut, through each intervention surgery completion (minute) when the skin is closed
measure: Length of hospital stay
timeFrame: 1 year; The date from the patients had been admitted to discharge
measure: Amount of blood loss
timeFrame: 1 day; Start from the skin's is cut through surgery period and postoperative until the drain bottle was removed.
measure: Radiographic outcomes: lumbar slip percentage
timeFrame: 1 year; Preoperative and post-operative at 0,6 and 12 months
measure: Radiographic outcomes: Slip angle
timeFrame: 1 year; Preoperative and post-operative at 0,6,12 months
measure: Radiographic outcomes: lumbar lordosis degree
timeFrame: 1 year; Preoperative and post-operative at 0,6,12 months
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Queen Savang Nadhana Memorial Hospital
Study officials:
References: