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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Coastal Orthopedics & Sports Medicine
• Collaborator: Vertos Medical, Inc.

Criteria

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.