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

Coastal Orthopedics & Sports Medicine

Status and phase: Completed; Phase 4

Conditions: Lumbar Spinal Stenosis

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00995371

VMD001LB

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Vertos mild® Minimally-Invasive Lumbar Decompression

Active Comparator group

Description:

Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.

Treatment:

Device: MILD® (Minimally Invasive Lumbar Decompression)

Epidural Steroid Injection

Active Comparator group

Description:

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.

Treatment:

Drug: Epidural Steroid Injection