Impact of degenerative spondylolisthesis on outcomes of endoscopic surgery for spinal stenosis
Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective Cohort Trial Protocol
This study is testing how degenerative spondylolisthesis affects recovery after endoscopic surgery for lumbar spinal stenosis in patients aged 50-80 who haven't found relief from other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Beijing Friendship Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06394089 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate how degenerative spondylolisthesis affects the clinical outcomes of unilateral biportal endoscopy in patients with lumbar spinal stenosis. It will involve a single-center, prospective cohort design, focusing on patients aged 50-80 who have been diagnosed with lumbar spinal stenosis affecting 1-2 vertebral levels and have not responded to conservative treatment. The study will assess the effectiveness of the surgical intervention in this specific patient population, providing valuable insights into their recovery and overall outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50-80 with lumbar spinal stenosis and degenerative spondylolisthesis of less than grade II who have not benefited from conservative treatment.
Not a fit: Patients with isthmic lumbar spondylolisthesis, grade II or higher degenerative spondylolisthesis, or other significant spinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical decision-making and improve recovery outcomes for patients with lumbar spinal stenosis and degenerative spondylolisthesis.
How similar studies have performed: While similar studies have explored outcomes of endoscopic surgery for spinal stenosis, this specific focus on degenerative spondylolisthesis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality
- Beijing Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiang Li
- Email: muzixiangxin2022@163.com
- Phone: +86 10 6313 9155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.