Status:
UNKNOWN
MIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Spinal Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Lumbar spinal stenosis (LSS) is one of the most common degenerative spine diseases in older people and is associated with mechanical low back pain, radiculopathy and/or neurological claudication. The ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04318795
Start Date
June 1 2020
End Date
December 31 2025
Last Update
March 26 2020
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