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MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study (MiDAS I)

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ClinicalTrials.gov Identifier: NCT00956631
Recruitment Status : Completed
First Posted : August 11, 2009
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Vertos Medical, Inc.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lumbar Spinal Stenosis
Intervention Procedure: Interlaminar Decompression
Enrollment 78
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Mild Procedure
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 78
Completed 62
Not Completed 16
Arm/Group Title Mild Procedure
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
<=18 years
0
   0.0%
Between 18 and 65 years
23
  29.5%
>=65 years
55
  70.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants
70  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Female
46
  59.0%
Male
32
  41.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 78 participants
78
1.Primary Outcome
Title Mean Change in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
Hide Description 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.
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
All available treated patients at Month 6.
Arm/Group Title Mild Procedure
Hide Arm/Group Description:
Percutaneous decompression with the mild device kit.
Overall Number of Participants Analyzed 62
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.21
(2.29 to 4.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild Procedure
Comments The mean change from baseline was assessed for VAS using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used throughout. A hypothetical average improvement of zero was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
2.29 to 4.13
Estimation Comments [Not Specified]
2.Other Pre-specified Outcome
Title 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.
Hide Description 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).
Time Frame Baseline and Six months
Hide Outcome Measure Data
Hide Analysis Population Description
All available participants at Month 6.
Arm/Group Title Mild Procedure
Hide Arm/Group Description:
Percutaneous lumbar decompression with the mild device kit.
Overall Number of Participants Analyzed 62
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
17.58
(12.33 to 22.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mild Procedure
Comments The mean change from baseline was assessed for ODI using a paired t-test. The resulting p-values are to be considered as descriptive statistics. Two-sided test with 5% Type I error was used. A hypothetical average improvement of zero was used.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.58
Confidence Interval (2-Sided) 95%
12.33 to 22.83
Estimation Comments [Not Specified]
3.Other Pre-specified Outcome
Title 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.
Hide Description 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.
Time Frame Baseline and Six Months
Hide Outcome Measure Data
Hide Analysis Population Description
All available participants were analyzed at six months.
Arm/Group Title Mild Procedure
Hide Arm/Group Description:
Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated using the mild® device kit in a percutaneous lumbar decompression procedure.
Overall Number of Participants Analyzed 62
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
7.11
(3.62 to 10.60)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mild Procedure
Hide Arm/Group Description 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.
All-Cause Mortality
Mild Procedure
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Mild Procedure
Affected / at Risk (%)
Total   0/78 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mild Procedure
Affected / at Risk (%)
Total   0/78 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP of Clinical, Regulatory and Quality
Organization: Vertos Medical
Phone: 9493490008 ext 216
EMail: cmyers@vertosmed.com
Layout table for additonal information
Responsible Party: Vertos Medical, Inc.
ClinicalTrials.gov Identifier: NCT00956631    
Other Study ID Numbers: MiDAS I
First Submitted: August 7, 2009
First Posted: August 11, 2009
Results First Submitted: January 4, 2013
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2013