Trial Outcomes & Findings for MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study (NCT NCT01082159)

Results Overview

The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant. The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

55 participants

Primary outcome timeframe

Baseline and Month 6

Results posted on

2013-04-01

Participant Flow

Patients were enrolled from July 2008 through January 2010.

Participant milestones

Participant milestones
Measure	Lumbar Decompression Single arm cohort having percutaneous decompression using the mild Device Kit
Overall Study STARTED	55
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lumbar Decompression n=55 Participants Single arm cohort having percutaneous decompression using the mild Device Kit
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	34 Participants n=5 Participants
Age Continuous	68.3 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Month 6

Population: All available participants who reported Month 6 outcomes are included in this analysis.

The 10-point Visual Analog Scale (VAS)rates 'no pain' as zero and 'worst pain imaginable' as ten. VAS mean improvement greater than or equal to 2 points is considered clinically relevant. The change from baseline to Month 6 is presented below where a positive value represents the baseline value minus the 6 month value.

Outcome measures

Outcome measures
Measure	Lumbar Decompression n=46 Participants Single arm cohort having percutaneous decompression using the mild Device Kit
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).	3.59 units on a scale Interval 2.76 to 4.42

PRIMARY outcome

Timeframe: Baseline and Month 6

Population: All available patients at 6 months are reported below.

Oswestry Disability Index (ODI) measures permanent functional disability using questions regarding activities of daily living (ADL), specifically disturbance of ADL related to chronic back pain. Higher scores indicate a 'more limited' life. The ten topics of the ODI are rated from zero (no pain/limitation) to five (high pain/very limited physically). The worst possible score is 50 (100% disability) with the best score being zero (0% disability).Change from baseline to 6 months is presented below, where a positive value represents the baseline value minus the 6 month value.

Outcome measures

Outcome measures
Measure	Lumbar Decompression n=46 Participants Single arm cohort having percutaneous decompression using the mild Device Kit
Function as Measured Subjectively by the Oswestry Disability Index Questionnaire	12.17 units on a scale Interval 6.64 to 17.71

PRIMARY outcome

Timeframe: Baseline and Month 6

Population: All participants at month 6 who completed all questionnaire fields necessary to analyze PCS data according to guidelines.

The SF-12 is a validated norm-based scoring tool used to determine treatment outcomes. The PCS summary measure shows the impact of the treatment on the patients abilities to conduct their usual physical activities. Clinical relevance of PCS is established by baseline to post-treatment improvement of 2 to 3 points. Norm-based scoring is used so that 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.

Outcome measures

Outcome measures
Measure	Lumbar Decompression n=42 Participants Single arm cohort having percutaneous decompression using the mild Device Kit
Quality of Life Changes as Determined by Short Form 12-question (SF-12) Survey Specifically Related to Physical Component Score (PCS).	8.32 units on a scale Interval 5.72 to 10.92

Adverse Events

Lumbar Decompression

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

VP Clinical Research

Vertos Medical

Phone: 949-349-0008

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60