Spinal Stenosis Clinical Trial
Official title:
Minimally Invasive Spinal Decompression (MIS-D) Versus Minimally Invasive Spinal Decompression and Fusion (MIS-TLIF) for the Treatment of Lumbar Spinal Stenosis (LSS): A Prospective Randomized Controlled Trial
Verified date | March 2020 |
Source | Third Affiliated Hospital, Sun Yat-Sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Third Affiliated Hospital, Sun Yat-Sen University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in Oswestry Disability Index (ODI) score from baseline | The Oswestry Disability Index (ODI) is widely used to assess chronic low back pain. It contains ten sections including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The ODI is ranging from 0 to 100, with higher scores indicating more disability related to pain. | preoperatively and 2 month, 6 months, 1 year,2 years and 5 years postoperatively | |
Secondary | change in European Quality of Life-5 Dimensions (EQ-5D) from baseline | The EQ-5D is a widely used instrument to assess health-related quality of life. Five questions(Mobility, Self-care, activities of daily living, Pain and Anxiety) are categorical (1-3 scale) and one question is on interval level (0-100).The EQ-5D is ranging from 0 to 1, with a higher score indicating better quality of life. | preoperatively and 2 month, 6 months, 1 year,2 years and 5 years postoperatively | |
Secondary | change in visual analog scales (VAS) from baseline | The VAS score is commonly used for pain assessment, which is ranging from 0 to 10, with higher scores indicating more severe pain | preoperatively and 2 month, 6 months, 1 year,2 years and 5 years postoperatively | |
Secondary | MacNab criteria | The patient is asked to rate his level of well-being, generally after surgery. The patient choose one of the four: Excellent, Good, Fair, Poor. | 2 month, 6 months, 1 year,2 years and 5 years postoperatively |
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