Trial Outcomes & Findings for The Vertos MILD™ Preliminary Patient Evaluation Study (NCT NCT00749073)
NCT ID: NCT00749073
Last Updated: 2013-04-10
Results Overview
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.
COMPLETED
NA
10 participants
Baseline and Six Months
2013-04-10
Participant Flow
Study enrolled between September 2008 and January 2009. Recruitment derived from patient pool of complex cases, all with confirmed presence of hypertrophic ligament, wait-listed for decompression laminectomy.
Participant milestones
| Measure |
Mild Percutaneous Lumbar Decompression
The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Vertos MILD™ Preliminary Patient Evaluation Study
Baseline characteristics by cohort
| Measure |
Mild Percutaneous Lumbar Decompression
n=10 Participants
The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
62.9 years
STANDARD_DEVIATION 12.84 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Six MonthsPopulation: All available treated patients at six months post treatment. Mean change from baseline to Month 6 was reported.
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.
Outcome measures
| Measure |
Mild Percutaneous Lumbar Decompression
n=10 Participants
The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
|
|---|---|
|
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
|
3.3 units on a scale
Standard Deviation 2.95
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: All treated patients having six month follow-up were included.
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.
Outcome measures
| Measure |
Mild Percutaneous Lumbar Decompression
n=10 Participants
The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
|
|---|---|
|
Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire
|
19.4 units on a scale
Standard Deviation 22.73
|
PRIMARY outcome
Timeframe: Baseline and Six monthsPopulation: All available treated patients with six month follow-up.
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.
Outcome measures
| Measure |
Mild Percutaneous Lumbar Decompression
n=10 Participants
The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression.
|
|---|---|
|
Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.
|
6.14 units on a scale
95% Confidence Interval 9.31 • Interval 4.4 to 11.74
|
Adverse Events
Mild Percutaneous Lumbar Decompression
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