The Vertos MILD™ Preliminary Patient Evaluation Study
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|ClinicalTrials.gov Identifier: NCT00749073|
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : April 4, 2013
Last Update Posted : April 10, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Spinal Stenosis||Device: Minimally Invasive Lumbar Decompression (MILD™)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-center, Prospective, Clinical Study to Assess the Clinical Application and Outcomes of Minimally Invasive Lumbar Decompression With the MILD™ Devices in Patients With Symptomatic Central Foraminal Lumbar Spinal Stenosis.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Percutaneous Lumbar Decompression procedure
mild percutaneous lumbar decompression procedure
Device: Minimally Invasive Lumbar Decompression (MILD™)
The arthroscopic devices in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
- Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). [ Time Frame: Baseline and Six Months ]Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value.
- Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire [ Time Frame: Baseline and Month 6 ]Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability.
- Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey. [ Time Frame: Baseline and Six months ]The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00749073
|Royal University Hospital|
|Saskatoon, Saskatchewan, Canada, S7N 0W8|
|Principal Investigator:||Daryl R Fourney, MD, FRCSC, FACS||University of Saskatchewan, Royal University Hospital, Divison of Neurosurgery|