Conditions: Lumbar Spinal Stenosis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 138
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Patients receiving percutaneous decompression using the mild® Device Kit. arm 2: Injection of epidural steroids into the lumbar spine

Interventions: intervention 1: Percutaneous Lumbar Decompression 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: