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

Queen Savang Vadhana Memorial Hospital, Thailand

Status

Not yet enrolling

Conditions

Lumbar Spinal Stenosis

Lumbar Degenerative Disease

Degenerative Lumbar Spondylolisthesis

Treatments

Procedure: Lumbar Endoscopic - Unilateral Laminotomy for Bilateral Decompression

Study type

Interventional

Funder types

Other

Identifiers

NCT06749314

024/2567

Details and patient eligibility

About

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.

Full 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

Enrollment

66 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.