Comparisons Therapeutic Effects of Different PELD Procedure on LSS. (NCT04314453) | Clinical Trial Compass
CompletedNot Applicable
Comparisons Therapeutic Effects of Different PELD Procedure on LSS.
140 participantsStarted 2014-01-01
Plain-language summary
Different procedure of percutaneous endoscopic lumbar discectomy (PELD) was with ventral decompression of dural sac on the lumbar spinal stenosis remains unkonwn.The traditional transforaminal endoscopic spine system (TESSYS) of PELD has been used in clnical for many years, but cannot achieve dorsal decompression. A newly developed modified TESSYS procedure, "U" route PELD combining ventral and dorsal decompression was introduced. Nevertheless, the superior between TESSYS and "U" route PELD procedures on treating LSS remains unknown. This study is desinged to recruit degenerative lumbar spinal stenosis patients who underwent TESSYS or "U" rout PELD, recruited from January 2014 to December 2017. These patients will be followed up for 2 years, and assessed the minimum dura sac cross sectional area (mDCSA) by MRI, and visual analogue scale (VAS) and Oswestry Disability Index (ODI) at pre- and post-operation. The global clinical outcomes were evaluated using modified MacNab criteria postoperatively. Thus, comprehensively evaluate the safety and therapeutic effects of the two PELD procedures on LSS treatments.
Who can participate
Age range
18 Years – 85 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:
* (1) patients with the diagnosis of degenerative lumbar spinal stenosis (LSS) (central stenosis with or without lateral recess stenosis) on mono or double segments, with the imaging evidence of magnetic resonance images (MRI) and computed tomography (CT); (2) patients presented low back pain, limp and sciatica, and have accepted conservative treatment more than 3 months but failed in symptoms relief; (3) patients agreed to accept TESSYS or the "U" route PELD procedure over other spinal surgeries; (4) patients had lumbar MRI imaging examines in our hospital at pre- and post-operation.
Exclusion Criteria:
* (1) patients with spinal instability, including dynamic instability or more than Grade II spondylolisthesis; (2) patients had spinal surgical history; (3) patients with peripheral nerve disease, systematic infection, bleeding diathesis or high risk of bleeding that cannot tolerate the surgery; (4) patients with mental illness and were uncooperative; (5) patients lost to the follow up.
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
Pain assessed by Visual Analogue Scale
Timeframe: Preoperation to postoperative 2 years.
2
Oswestry Disability Index (ODI)
Timeframe: Preoperation to postoperative 2 years.
Trial details
NCT IDNCT04314453
SponsorSecond Affiliated Hospital of Wenzhou Medical University