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Recruiting NCT06394089

Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol

— Observational Degenerative Spondylolisthesis Lumbar Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Degenerative Spondylolisthesis, Lumbar Spinal Stenosis. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective Cohort Trial Protocol

Overview

A single-center, prospective cohort trial aims to provide stronger evidence regarding the impact of degenerative spondylolisthesis on the clinical outcome of unilateral biportal endoscopy for lumbar spinal stenosis

Primary outcome measures

  • Oswestry Disability Index (ODI) [Time frame: From enrollment to the end of follow-up at 2 year]
Secondary outcome measures (12)
  • X-ray [Time frame: From enrollment to the end of follow-up at 2 year]
  • Computed tomography (CT) scan [Time frame: From enrollment to the end of follow-up at 2 year]
  • Magnetic resonance imaging (MRI) [Time frame: From enrollment to the end of follow-up at 2 year]
  • Surgical complication [Time frame: From enrollment to the end of follow-up at 2 year]
  • Visual analog scale (VAS) score for lower back pain [Time frame: From enrollment to the end of follow-up at 2 year]
  • Visual analog scale (VAS) score for leg pain [Time frame: From enrollment to the end of follow-up at 2 year]
  • Operative time [Time frame: Immediately after the surgery]
  • Intraoperative blood loss [Time frame: Immediately after the surgery]
  • Postoperative hospital stays [Time frame: Immediately after the discharge]
  • Japanese Orthopaedic Association (JOA) score [Time frame: From enrollment to the end of follow-up at 2 year]
  • Modified MacNab criteria [Time frame: From enrollment to the end of follow-up at 2 year]
  • Improvement ratio of Visual analog scale (VAS) score for lower back pain [Time frame: From enrollment to the end of follow-up at 2 year]

Eligibility criteria

Inclusion criteria

  • Age range: 50-80 years
  • Diagnosis of LSS affecting 1-2 vertebral levels
  • Predominant manifestation of neurogenic intermittent claudication, with ineffective conservative treatment for at least 3 months
  • Presence of lumbar DS of less than grade II and absence of spine instability
  • Willingness to participate in the study and complete follow-up assessments.

Exclusion criteria

  • Diagnosis of isthmic lumbar spondylolisthesis or lumbar DS of grade ≥II
  • Evidence of instability at the affected vertebral level (intervertebral angle change > 15° and/or vertebral translation ≥ 4.5 mm in standing flexion-extension radiographs of the lumbar spine)
  • History of prior surgery at the affected vertebral level
  • Presence of scoliosis with a Cobb angle >20º
  • Presence of other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)
  • Medical disorders that preclude surgical tolerance
  • Participation in other clinical research projects related to the treatment of lumbar spinal stenosis.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Friendship Hospital — Beijing

Publications

  • Liu Y, Li G, Yu L, Sun H, Zhu B, Fei Q, Lo Y, Yang Y, Tan H, Li X. Degenerative spondylolisthesis and unilateral biportal endoscopic decompression for lumbar spinal stenosis: a single-center, prospective cohort trial protocol. BMC Musculoskelet Disord. 2025 Oct 1;26(1):900. doi: 10.1186/s12891-025-09179-6. PMID 41034885

Identifiers

NCT: NCT06394089 · 2023-P2-293-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗