The Vertos MILD™ Preliminary Patient Evaluation Study (NCT00749073) | Clinical Trial Compass
CompletedNot Applicable
The Vertos MILD™ 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 (MILD™) 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 MILD™ treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.