Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control. Subjects in the control group are able to crossover and receive MILD after completion of 12-month follow-up. The study will provide objective functional improvement data for patients treated with the mild Procedure as first-line therapy in a real-world setting.
The study will follow participants treated in the MILD plus CMM group and crossover participants for up to 5 years on annual bases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
155
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. Other Name: MILD lumbar decompression
CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Newport Heache & Pain
Newport Beach, California, United States
Centura Spine Center
Colorado Springs, Colorado, United States
Mean Change in Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) is a widely-used validated questionnaire use to measure a patient's functional disability. The total score ranges from 0 (no disability) - 100 (complete disability). Score categories: 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), 81-100 (bed bound or have an exaggerating).
Time frame: Mean Change in Oswestry Disability Index (ODI) baseline to 12 month
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...and 8 more locations