Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy… (NCT06394089) | Clinical Trial Compass
RecruitingNot Applicable
Effect of Degenerative Spondylolisthesis on the Clinical Outcome of Unilateral Biportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol
China150 participantsStarted 2024-03-01
Plain-language summary
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
Who can participate
Age range
50 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
What they're measuring
1
Oswestry Disability Index (ODI)
Timeframe: From enrollment to the end of follow-up at 2 year