Status:
COMPLETED
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Lead Sponsor:
Vertos Medical, Inc.
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.
Eligibility Criteria
Inclusion
- Symptomatic Lumbar Spinal Stenosis (LSS) primarily caused by dorsal element hypertrophy.
- Prior failure of conservative therapy.
- 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 12 weeks of follow-up.
- Consistent with the intended labeling statement for use.
- Able to use all package components to perform the procedure.
- A signed Informed Consent Form is obtained from the patient.
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 disk protrusion or osteophyte formation.
- Excessive / symptomatic facet hypertrophy.
- Bleeding disorders and/or current use of anti-coagulants.
- Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment.
- Epidural steroids within prior three weeks.
- Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.).
- Any potential wound healing pathologies that may 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.
- Pregnancy.
- Intended treatment that is defined by the product labeling contraindications.
- On Workman's Compensation or considering litigation associated with back pain.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00956631
Start Date
July 1 2008
End Date
April 1 2012
Last Update
April 4 2013
Active Locations (13)
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1
NEA Clinic
Jonesboro, Arkansas, United States, 72401
2
UCLA
Los Angeles, California, United States, 90095
3
Napa Pain Institute
Napa, California, United States, 94558
4
Scripps, Division of Orthopedic Surgery
San Diego, California, United States, 92037