MIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis (NCT04318795) | Clinical Trial Compass
UnknownNot Applicable
MIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis
80 participantsStarted 2020-06-01
Plain-language summary
The purpose of this study is to evaluate the effectiveness of two minimal invasive spine surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF), for patients diagnosed with lumbar spinal stenosis in terms of clinical outcomes, complications, reoperations, and other perioperative data.
Who can participate
Age range
18 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:
* Intermittent claudication with pain or numbness or weakness of lower limb(s) with or without low back pain
* An imaging study (MRI or CT) showing single level lumbar spinal stenosis
Exclusion Criteria:
* Insufficient conservative treatment (6 weeks)
* Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
* Previous spinal surgery
* Other comorbid conditions that contraindicating surgery
* Possible pregnancy that contraindicating radiological examination
* Age less than 18 years old
* Combination with 2°spondylolisthesis or segmental instability (slip distance \>4mm or angle change \>10° in dynamic plain film)
* Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
* Equal to or more than two responsible level
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
change in Oswestry Disability Index (ODI) score from baseline
Timeframe: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
Trial details
NCT IDNCT04318795
SponsorThird Affiliated Hospital, Sun Yat-Sen University