Trial Outcomes & Findings for MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study (NCT NCT00956631)
NCT ID: NCT00956631
Last Updated: 2013-04-04
Results Overview
The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.
COMPLETED
PHASE4
78 participants
Baseline and Six Months
2013-04-04
Participant Flow
Patient enrollment July 2008 to January 2010 at fourteen study sites. Treatments were performed in an outpatient setting at an hospital outpatient or ambulatory surgery center.
After enrollment and prior to surgery patient was excluded if patient had procedure or trauma at study treatment level, used acetylsalicylic acid (ASA) or non-steroidal anti-inflammatory drug (NSAID) within five days of treatment, epidural steroid injection (ESI) within 3 weeks of treatment.
Participant milestones
| Measure |
Mild Procedure
Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
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|---|---|
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Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
Baseline characteristics by cohort
| Measure |
Mild Procedure
n=78 Participants
Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
55 Participants
n=5 Participants
|
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Age Continuous
|
70 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
78 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Six MonthsPopulation: All available treated patients at Month 6.
The 10-point Visual Analog Scale rates 'no pain' as zero and 'worst pain imaginable' as ten. Visual analog scores of mean improvement greater than or equal to 2.0 are clinically relevant. The change from baseline to six months is reported below, where a positive value represents the baseline value minus the 6 month value.
Outcome measures
| Measure |
Mild Procedure
n=62 Participants
Percutaneous decompression with the mild device kit.
|
|---|---|
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Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
|
3.21 units on a scale
95% Confidence Interval p<0.0001 • Interval 2.29 to 4.13
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Six monthsPopulation: All available participants at Month 6.
Change from baseline to month six is reported below, where a positive value represents baseline value minus 6 month value. 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) based on typical pain and/or physical limitations. The worst possible score is 50 (100 % disability) and best would be zero (0% disability).
Outcome measures
| Measure |
Mild Procedure
n=62 Participants
Percutaneous decompression with the mild device kit.
|
|---|---|
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Function Measure Oswestry Disability Index (ODI). Measures Permanent Functional Disability Through Questions Which Characterize Disturbance of Activities of Daily Living (ADL) Resulting From Chronic Back Pain. Higher Scores Indicate Greater Disability.
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17.58 units on a scale
Interval 12.33 to 22.83
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OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Six MonthsPopulation: All available participants were analyzed at six months.
Minimally Important Difference (MID) is a measure of true clinical relevance of a difference. The MID for mean Physical Component Score (PCS) improvement is 2 to 3 points. SF-12v2 is a validated tool that uses norm-based scoring to determine treatment outcomes \& is a generic measure, as opposed to one that targets a specific age, disease, or treatment group. The SF-12v2 asks for patient views about their health to determine how they feel \& how well they are able to conduct their usual activities. The data for the 2 summary scales and 8 survey scales are normalized so each scale has the same mean (50 points) \& the same standard deviation (10 points) in the general 1998 U.S. population. By using this method, anytime a scale is below 50, health status is below average, \& each point is one-tenth of a standard deviation. The PCS summary measure takes into account the correlations among the Health Survey scales, \& shows the broad impact which was of interest in this study.
Outcome measures
| Measure |
Mild Procedure
n=62 Participants
Percutaneous decompression with the mild device kit.
|
|---|---|
|
Quality of Life Physical Component Score (PCS) as Measured by the 12-question Short Form Survey Version 2 (SF-12v2). Change From Baseline Mean to Six Month Mean is Reported Below. A Positive Value Represents the 6 Month Value Minus the Baseline Value.
|
7.11 units on a scale
95% Confidence Interval 11.32 • Interval 3.62 to 10.6
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Adverse Events
Mild Procedure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60