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 range18 Years
SexALL
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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
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