Degenerative spondylolisthesis and unilateral biportal endoscopic decompression for lumbar spinal stenosis: a single-center, prospective cohort trial protocol.
Yuquan Liu, Guangpeng Li, Lingjia Yu...
https://pubmed.ncbi.nlm.nih.gov/41034885Actively Recruiting
Age: 50Years - 80Years
All Genders
ID06394089
Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: a Single-center, Prospective Cohort Trial Protocol
Led by Beijing Friendship Hospital · Updated on 2025-06-06
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the impact of degenerative spondylolisthesis on the results of unilateral biportal endoscopy surgery for lumbar spinal stenosis. This prospective cohort trial is conducted at a single center and aims to provide stronger evidence on how the presence of degenerative spondylolisthesis affects clinical outcomes for patients undergoing this procedure. The study focuses on adults aged 50 to 80 years with lumbar spinal stenosis and compares those with and without degenerative spondylolisthesis. Participants are divided into two groups based on their condition: one group includes patients with lumbar spinal stenosis combined with degenerative spondylolisthesis of Meyerding grade I, and the other group includes patients with lumbar spinal stenosis only. Both groups will undergo unilateral biportal endoscopy treatment. The study monitors patients from enrollment and follows them for 2 years to assess various clinical and imaging outcomes. Throughout the study, participants will undergo assessments including the Oswestry Disability Index (ODI), X-rays, CT scans, and MRI from enrollment through the 2-year follow-up. Additional measures include surgical complications, pain scores for lower back and leg pain, operative time, blood loss, hospital stay duration, and various blood tests within 3 days after surgery. Researchers will track improvements in pain, function, and disability scores to evaluate the surgery's impact over time.
CONDITIONS
Brief Title
Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol
Who Can Participate
Age: 50Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age range: 50-80 years
- Diagnosis of lumbar spinal stenosis affecting 1-2 vertebral levels
- Neurogenic intermittent claudication not improved after at least 3 months of conservative treatment
- Lumbar degenerative spondylolisthesis less than grade II without spine instability
- Willingness to participate and complete follow-up assessments
You will not qualify if you...
- Isthmic lumbar spondylolisthesis or lumbar degenerative spondylolisthesis grade II or higher
- Instability at the affected vertebral level (intervertebral angle change > 15° or vertebral translation ≥ 4.5 mm)
- History of prior surgery at the affected vertebral level
- Scoliosis with a Cobb angle greater than 20°
- Other lumbar spine conditions (infection, tumor, fracture, neurological diseases)
- Medical conditions preventing surgical tolerance
- Participation in other lumbar spinal stenosis clinical research
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospital stay duration as per routine care
Participants undergo unilateral biportal endoscopy surgery for lumbar spinal stenosis and receive immediate post-operative care.
1 visit for surgery and hospital stay until discharge
Post-operative Follow-up
Duration - Up to 2 years
Participants are followed for up to 2 years after surgery to assess clinical outcomes and recovery.
Regular follow-up visits over 2 years
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
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Research Team
X
Xiang Li
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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