Status:
WITHDRAWN
Indirect vs. Direct Decompression for Treatment of Central Stenosis: RCT
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
Patients With Spinal Stenosis Indicated for LLIF
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a prospective, randomized clinical trial of patients undergoing 1-level lateral lumbar spinal fusion. This study seeks to randomize patients indicated for Lateral Lumbar Interbody Fusion (LLIF...
Detailed Description
While indirect decompression has been largely accepted as a strategy to treat foraminal stenosis, there is some disagreement regarding its efficacy in treating patients with central and lateral recess...
Eligibility Criteria
Inclusion
- Fusion indicated by the treating surgeon. Fusion may be indicated for one or more of the following reasons:
- Mobile degenerative spondylolisthesis
- Severe vertical foraminal stenosis
- Adjacent segment degeneration and/or degenerative disc disease with suspected discogenic pain
- One-level central canal stenosis
- WITH neurogenic claudication
- As measured in preoperative MRI
- Oswestry Low Back Pain Disability Questionnaire score \> 35% (18/50)
- Failed 3 months of conservative treatment
- Willing to give written informed consent and psychosocially, mentally, and physically able to comply fully with protocol, including adhering to follow-up schedule and requirements, and filling out forms
Exclusion
- Multilevel central canal stenosis
- Patients with vertebral endplate dimensions that are too small to allow for safe placement of an intervertebral cage
- Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum
- Prior surgery at index disc level (discectomy, decompression, or fusion)
- History of spinal or vertebral infection of the lumbar spine
- History of vertebral fracture of the lumbar spine
- Current pregnancy or interest in becoming pregnant over the next 1 year
- Active infection-systemic or local
- Non-English speakers
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04708977
Start Date
February 8 2021
End Date
September 29 2021
Last Update
October 11 2021
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021