Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis

Phase 4

Completed

Interventions: Device: MILD® (Minimally Invasive Lumbar Decompression)
Drug: Epidural Steroid Injection

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.

Recruitment & Eligibility

Inclusion Criteria

Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
Prior failure of conservative therapy and ODI Score >20%.
Radiologic evidence of LSS (L3-L5), Ligamentum flavum >2.5mm, confirmed by pre-op MRI and/or CT.
Central canal cross sectional area ≤ 100 square mm.
Anterior listhesis ≤ 5.0mm.
Able to walk at least 10 feet unaided before being limited by pain.
Available to complete 26 weeks of follow-up.
A signed Informed Consent Form is obtained from the patient.
Adults at least 18 years of age.

Exclusion Criteria

Prior surgery at intended treatment level.
History of recent spinal fractures with concurrent pain symptoms.
Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.)
Significant / symptomatic disc protrusion or osteophyte formation.
Excessive / symptomatic facet hypertrophy.
Bleeding disorders and/or current use of anti-coagulants.
Use of ASA and/or NSAID within 5 days of treatment.
Pregnant and/or breastfeeding.
Epidural steroids previously administered (not ESI naive)
Wound healing pathologies deemed to compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD.
Dementia and/or inability to give informed consent.
Inability of the patient to lie prone for any reason with anesthesia support (e.g. COPD, obesity, etc.).
On Workman's Compensation or considering litigation associated with back pain.

Arm && Interventions

Group	Intervention	Description
Vertos mild® Minimally-Invasive Lumbar Decompression	MILD® (Minimally Invasive Lumbar Decompression)	Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
Epidural Steroid Injection	Epidural Steroid Injection	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.

Primary Outcome Measures

Name	Time	Method
Mean Change in VAS	Baseline and 26 weeks After ESI to mild cross-over	Visual Analog Scale (VAS) - a validated ten point scale where ten is the worst possible pain and zero represents complete lack of pain. The change from baseline to 26 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value.
Mean Change in ODI	Baseline and 26 weeks After ESI to mild cross-over	Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance in ADL related to chronic back pain. Higher score indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). Calculated values range from zero (0% disability) to 100 (100% disability). The change from baseline to 6 weeks for all participants is presented below, where a positive value represents the baseline value minus the 26 week value

Secondary Outcome Measures