Status:
COMPLETED
Study of Epidural Steroid Injection (ESI) Versus Minimally Invasive Lumbar Decompression (Mild®) in Patients With Symptomatic Lumbar Central Canal Stenosis
Lead Sponsor:
Coastal Orthopedics & Sports Medicine
Collaborating Sponsors:
Vertos Medical, Inc.
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 symp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00995371
Start Date
August 1 2009
End Date
May 1 2013
Last Update
November 15 2013
Active Locations (1)
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1
Coastal Orthopedics & Sports Medicine
Bradenton, Florida, United States, 34209