Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
302
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
Synovation Medical Group
Chula Vista, California, United States
Spine Intervention Medical Group/Fresno Surgical Hospital
Fresno, California, United States
The Spine Institute
Murrieta, California, United States
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.
Time frame: 12 months
Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months
Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.
Time frame: 12 months
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.
Time frame: 12 months
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