Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Keywords: Lumbar Spinal Stenosis Spinal Stenosis Neurogenic Claudication
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 302
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: The MILD procedure is an image-guided minimally-invasive lumbar decompression arm 2: An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.

Interventions: intervention 1: MILD Procedure intervention 2: Epidural Steroid Injection
Intervention descriptions: intervention 1: 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. intervention 2: Injection of epidural steroids into the lumbar spine

Protocol document: