This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal stenosis exhibiting neurogenic claudication.
The study was initially designed as a randomized trial. Due to difficulty of enrollment, the study was amended and converted to an observational comparative study with study arm being self-selected by the patient.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
Injection of epidural steroids into the lumbar spine
Percentage of Participants With a 2-point Improvement in Visual Analogue Scale
The primary endpoint for evaluating effectiveness will be the proportion of subjects in each group achieving at least a 2-point improvement from baseline in the Visual Analog Scale.
Time frame: 16 weeks
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