Status:
COMPLETED
LLIF Plus Posterior Decompression for Severe Lumbar Spinal Stenosis
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Lumbar Spine Degeneration
Lumbar Spinal Stenosis
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
Lateral lumbar interbody fusion (LLIF), as a minimally invasive technique, is an indirect decompression technique, and its decompression effect is not as thorough as traditional posterior decompressio...
Detailed Description
The current randomized controlled trial consists of two groups. Patients included in the study are with Schizas's stenosis grades C. Patients in one group received transpsoas lateral lumbar interbody ...
Eligibility Criteria
Inclusion
- Male and female patients who are 50 - 80 years of age.
- Patients who present with symptomatic Grade I or II degenerative spondylolisthesis at one or two contiguous lumbar levels between L1 and L5 and who are surgical candidates for interbody lumbar fusion surgery; symptoms should include radiculopathy and/or neurogenic claudication with or without back pain.
- Patients who have been unresponsive to at least 6 months of conservative treatments or who exhibit progressive neurological symptoms in the face of conservative treatment.
- Patients who understand the conditions of enrollment and are willing to sign an informed consent to participate in the study.
Exclusion
- Patients with lumbar pathologies requiring treatment at more than two levels.
- Patients who have had previous lumbar fusion surgery.
- Patients with congenital lumbar stenosis.
- Patients with radiographic confirmation of Grade IV facet joint disease or degeneration.
- Patients with noncontained or extruded herniated nucleus pulposus.
- Patients with active local or systemic infection.
- Patients with rheumatoid arthritis or other autoimmune disease.
- Patients who cannot undergo magnetic resonance imaging (MRI).
- Patients who are mentally incompetent.
- Patients with BMI over 30kg/m2 or less than 18 kg/m2.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04094220
Start Date
August 1 2019
End Date
December 30 2022
Last Update
December 29 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Affiliated Hospital of Medical College Zhejiang University
Hangzhou, Zhejiang, China, 310000