Biportal endoscopic decompression versus decompression with fusion for degenerative lumbar spondylolisthesis
Clinical Study on the Therapeutic Efficacy of Biportal Endoscopic Decompression Spine Surgery and Lumbar Decompression Fusion Surgery in the Treatment of Degenerative Lumbar Spondylolisthesis
The Fourth Affiliated Hospital of Zhejiang University School of Medicine · NCT07289737
This study will test whether biportal endoscopic decompression or standard decompression with fusion gives better pain relief, nerve recovery, and fewer complications for people aged 50–90 with degenerative lumbar spondylolisthesis who have not improved after conservative care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | The Fourth Affiliated Hospital of Zhejiang University School of Medicine (other) |
| Locations | 1 site (Yiwu, Zhejiang) |
| Trial ID | NCT07289737 on ClinicalTrials.gov |
What this trial studies
This is a prospective cohort in which patients with degenerative lumbar spondylolisthesis choose either dual-channel (biportal) endoscopic decompression or lumbar decompression with fusion, with standardized surgical protocols and detailed perioperative documentation. Baseline and postoperative pain and neurological function are measured using VAS, JOA, and ODI scores, and imaging with MRI/CT is collected. Operative details (duration, blood loss, intraoperative findings) and tissue specimens are recorded, and patients are followed at 1, 3, 6, 12, 24, and 36 months to compare pain relief, functional recovery, and complication rates.
Who should consider this trial
Good fit: Ideal candidates are people aged 50–90 with imaging-confirmed degenerative lumbar spondylolisthesis, chronic pain or neurologic symptoms that did not improve after at least three months of conservative treatment, and who can consent to either surgical option.
Not a fit: Patients with acute spinal cord compression, prior spinal surgery, severe deformity, severe osteoporosis, active spinal infection, or major uncontrolled medical or psychiatric comorbidities are unlikely to benefit from the procedures studied here.
Why it matters
Potential benefit: If successful, the biportal endoscopic approach could offer similar symptom relief with less tissue trauma, shorter recovery, and lower perioperative morbidity compared with fusion for selected patients.
How similar studies have performed: Previous case series and short-term observational reports have shown promising results for biportal endoscopic decompression in lumbar stenosis and select spondylolisthesis patients, but high-quality comparative long-term evidence versus fusion remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged between 50 and 90 years old with a confirmed diagnosis of degenerative lumbar spondylolisthesis; 2. Clinical symptoms include chronic pain, nerve compression, or motor dysfunction, confirmed by imaging studies (e.g., MRI or CT); 3. No significant improvement after at least 3 months of conservative treatment (e.g., medication, physical therapy), meeting surgical indications; 4. Understand and consent to the relevant procedures of this study, and sign the informed consent form. Exclusion Criteria: 1. Patients exhibiting acute spinal cord compression symptoms or requiring urgent surgical intervention; 2. Patients with a history of spinal surgery or conditions such as spinal deformities, severe osteoporosis, or active infections that may compromise surgical outcomes; 3. Patients with severe comorbidities affecting assessment, such as cardiovascular disease, liver or kidney failure, or uncontrolled diabetes; 4. Patients with psychiatric disorders or cognitive impairments preventing understanding or cooperation with the study process; 5. Patients with allergies to anesthetics or surgical equipment that may increase intraoperative risks.
Where this trial is running
Yiwu, Zhejiang
- 4th Affiliated Hospital, School of Medicine, Zhejiang University — Yiwu, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: xiang xue, MD
- Email: xuexiang@zju.edu.cn
- Phone: +86 057989935990
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.
Conditions: Lumbar Degenerative Spondylolisthesis, lumbar, ube