Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis; Constriction, Pathologic
Intervention: MILD® (Minimally Invasive Lumbar Decompression); Epidural Steroid Injection
Intervention description: Image guided minimally-invasive lumbar decompression performed with arthroscopic devices.; An Epidural Steroid Injection is injected into the space around the spinal cord and nerve roots called epidural space.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spinal Stenosis; Lumbar Spinal Stenosis; Laminotomy; Laminectomy; Spine Surgery

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.
    

Eligibility 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.