Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis Lumbar Spinal Stenosis Laminotomy Laminectomy Spine Surgery
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 38
Healthy volunteers: no

Brief summary:
This is a single-center, randomized, prospective, double-blind clinical study to assess the clinical application and outcomes with MILD® devices versus epidural steroid injection in patients with symptomatic moderate to severe central canal spinal stenosis.

Detailed description:

Arms:
arm 1: Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use. arm 2: Patients in the Epidural Steroid Injection (ESI) group will have ESI performed by appropriately trained physicians in accordance with product labeling and indications for use.

Interventions: intervention 1: MILD® (Minimally Invasive Lumbar Decompression) intervention 2: Epidural Steroid Injection
Intervention descriptions: intervention 1: Image guided minimally-invasive lumbar decompression performed with arthroscopic devices. intervention 2: An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.

Protocol document: