Multicenter Clinical Randomized Controlled Trial of Unilateral Biportal Endoscopic Spinal Surgery for Degenerative Grade 1 Spondylolisthesis Complicated With Lumbar Spinal Stenosis
China200 participantsStarted 2025-07-01
Plain-language summary
The research objective of this project is to clarify and compare the efficacy of the unilateral biportal endoscopy (UBE) technique and traditional open decompression, fusion and internal fixation surgery in the treatment of patients with Grade Ⅰ degenerative spondylolisthesis complicated with central spinal canal stenosis through high-quality, prospective, multicenter randomized controlled trials (RCTs), so as to provide high-level clinical research evidence for the expansion of UBE technique indications and its technical promotion.
Who can participate
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria Imaging findings: Single-segment Grade Ⅰ lumbar spondylolisthesis complicated with central spinal canal stenosis on imaging examinations; Clinical manifestations: Accompanied by intermittent claudication, radiating pain and numbness of the lower extremities, and other relevant neurological symptoms; Treatment history: No relief of symptoms after more than 3 months of conservative treatment; Informed consent: The patient and their family members are fully informed of the trial details, have signed the informed consent form, and agree to participate in the trial.
Exclusion Criteria Severe spondylolisthesis: Lumbar spondylolisthesis of Grade Ⅱ or higher; Non-degenerative or unstable conditions: Non-degenerative lumbar spine diseases, or significant confirmed lumbar instability; Special pathological or surgical history: Complicated with lumbar spine infection, tumor, trauma, or deformity; or with a history of previous lumbar spine surgery; Systemic comorbidities: Complicated with other systemic diseases that may significantly affect surgical efficacy (such as rheumatoid arthritis, severe osteoporosis, and severe mental illness).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.