Status:
COMPLETED
The Vertos MILD™ Preliminary Patient Evaluation Study
Lead Sponsor:
Vertos Medical, Inc.
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompressio...
Detailed Description
The Vertos MILD™ devices are used for image-guided Minimally Invasive Lumbar Decompression, referred to as the MILD™ procedure. This percutaneous procedure is performed under fluoroscopic image guidan...
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 \> 2.5 mm, confirmed by pre op MRI and/or CT.
- Central canal cross sectional area \< 100mm2.
- Anterior listhesis \< 2 - 3mm.
- Able to walk at least 10 feet unaided before being limited by pain.
- Available to complete 12 weeks of follow-up.
- A signed Informed Consent Form is obtained from the patient.
- Adults ≥ 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 disk protrusion or osteophyte formation.
- Excessive 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00749073
Start Date
September 1 2008
End Date
July 1 2009
Last Update
April 10 2013
Active Locations (1)
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1
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8