The Vertos MILDâ„¢ Preliminary Patient Evaluation Study (NCT00749073) | Clinical Trial Compass
CompletedNot Applicable
The Vertos MILDâ„¢ Preliminary Patient Evaluation Study
Canada10 participantsStarted 2008-09
Plain-language 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 Decompression (MILDâ„¢) treatment for lumbar spinal stenosis. In this study, patient-reported outcomes over a 3 month period following treatment will be collected by the investigator. Periodic surveys for each study subject's pain, functional status, quality of life and physical examination will track outcomes following MILDâ„¢ treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
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 disk protrusion or osteophyte formation.
✕. Excessive facet hypertrophy.
✕. Bleeding disorders and/or current use of anti coagulants.
What they're measuring
1
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
Timeframe: Baseline and Six Months
2
Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire
Timeframe: Baseline and Month 6
3
Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.