Lumbar Spinal Stenosis Clinical Trial
Official title:
Oblique Lateral Interbody Fusion Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion for Lumbar Spinal Stenosis
Verified date | February 2021 |
Source | Tang-Du Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The investigators will retrospectively study lumbar spinal stenosis patients who underwent OLIF or MIS-TLIF with percutaneous pedicle screw fixation between January 2016 and December 2019.The investigators will measure estimated blood loss, operative time, hospital stay, cost, reoperation, and complication incidence, visual analogue scale (VAS), Oswestry Disability Index (ODI), Japanese Orthopaedic Association (JOA), and Short Form-36 (SF-36) scores, discal and foraminal height, lumbar lordotic angle, and fusion status.The investigators will conduct to evaluate postoperative improvements, complications, and reoperation rates between patients with lumbar spinal stenosis (LSS) undergoing oblique lateral interbody fusion (OLIF) or minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF).
Status | Not yet recruiting |
Enrollment | 130 |
Est. completion date | March 29, 2021 |
Est. primary completion date | March 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: - LSS due to neurogenic claudication; Central stenosis or lateral stenosis who need surgery; Single-level, low-grade (Meyerding grade 1 or 2) isthmic spondylolisthesis or degenerative spondylolisthesis; and imaging findings consistent with the symptoms of LSS. Exclusion Criteria: - trauma, active infection, malignant tumors, spinal deformity, previous lumbar fusion, multi-segment fusion, multi-level, high-grade (Meyerding grade 3 or 4) isthmic spondylolisthesis or degenerative spondylolisthesis. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tang-Du Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry Disability Index (ODI), , and Short Form-36 (SF-36) scores; discal and foraminal height; lumbar lordotic angle; and fusion status. | Before surgery and at the last follow-up, the following information was recorded | 2 Years | |
Secondary | Japanese Orthopaedic Association (JOA) | Before surgery and at the last follow-up, the following information was recorded | 2 Years | |
Secondary | visual analogue scale (VAS) | Before surgery and at the last follow-up, the following information was recorded | 2 Years | |
Secondary | Short Form-36 (SF-36) scores | Before surgery and at the last follow-up, the following information was recorded | 2 Years | |
Secondary | Major Complication rate | 2 Years |
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