Degenerative spondylolisthesis and unilateral biportal endoscopic decompression for lumbar spinal stenosis: a single-center, prospective cohort trial protocol.

BACKGROUND

The recently developed unilateral biportal endoscopic (UBE) technique has proven to be an effective treatment for lumbar spinal stenosis (LSS). However, the association between preoperative degenerative spondylolisthesis (DS) and UBE decompression alone for LSS, as well as its progression post-surgery, remains unaddressed. Therefore, this prospective cohort study aims to investigate the association between preoperative DS and the clinical outcomes of UBE decompression alone for LSS.

METHODS AND ANALYSIS: This single-center, prospective cohort trial will recruit 150 participants with LSS affecting 1-2 vertebral levels. Enrolled patients will be classified into either the DS group (N = 50) or the non-DS group (n = 100) based on the presence of combined DS. The primary outcome will be assessed using the Oswestry Disability Index (ODI) at the 24-month postoperative follow-up for both groups. Secondary outcomes will include clinical, radiographic, and laboratory outcomes, as well as adverse events. Clinical outcomes will include the Japanese Orthopedic Association (JOA) score, visual analog scale (VAS) scores for lower back and leg pain, modified MacNab criteria, and measurements of operative time, blood loss, and length of postoperative hospital stay. Radiographic outcomes will include the progression of DS, spinal instability, enlargement ratio of the dural sac, bony decompression range, and preservation rate of the facet joint, assessed via postoperative X-ray, magnetic resonance imaging (MRI), or computed tomography (CT) scans. Laboratory outcomes will include postoperative inflammatory indicators like white blood cell count, percentage of neutrophils, and C-reactive protein level, and injury indicators such as creatine kinase level, lactate dehydrogenase level, and myoglobin level. Adverse events will be recorded to assess safety. Participants will be evaluated by a blinded assessor preoperatively and postoperatively at 3 days, 2 weeks, and 1, 3, 6, 12, and 24 months.

DISCUSSION: This study is designed to investigate the association between preoperative DS and the clinical outcomes of UBE decompression alone for LSS.

TRIAL REGISTRATION: The trail has been registered on April 7th, 2024, in the ClinicalTrials.gov (NCT06394089).