A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS) (DSS)
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|ClinicalTrials.gov Identifier: NCT01461005|
Recruitment Status : Terminated (FDA reclassified so all 522 studies were stopped,)
First Posted : October 27, 2011
Results First Posted : October 15, 2019
Last Update Posted : February 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Spondylolisthesis Neurologic Deficits Kyphosis Pseudarthrosis||Device: Dynamic Stabilization System (DSS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Dynamic Stabilization System
Dynamic Stabilization System (DSS) System
Device: Dynamic Stabilization System (DSS)
Dynamic Stabilization System
- Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure. [ Time Frame: 6 months ]The safety endpoint is defined as the incidence of serious or device related adverse events attributable to the device or procedure. Reoperations, revisions or removals of the Dynamic Stabilization System (DSS) System implant will be evaluated.
- Measurement of Lower Back Pain as Assessed by Visual Analog Scale [ Time Frame: 6 months ]Lower back pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
- Measurement of Right Leg Pain as Assessed by Visual Analog Scale [ Time Frame: 6 months ]Right leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
- Measurement of Left Leg Pain as Assessed by Visual Analog Scale [ Time Frame: 6 months ]Left leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
- Number of Participants With Improved Health as Measured by the EuroQOL Health Related Qualify of Life- 5 Dimensions-3 Level (EQ-5D-3L) Health Questionnaire Compared to Baseline. [ Time Frame: Pre-Op, 6 weeks, 6 months, 12 months, and 24 months ]The EQ-5D-3L is a standardized instrument used as a measure of health outcomes. It contains questions in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and provides a simple descriptive profile and single index for health status preference. In addition, there is a Visual Analog Scale (VAS). The VAS is the participant's rating of their health on a scale of 0 "worst imaginable health state" to 100 "best imaginable health state".
- Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI). [ Time Frame: 6 months ]ODI is a questionnaire that provides information on back and the affects on managing every day life by diving questions into 10 sections. The total possible score for each section is 0-5. The scores are then converted into percentages ranging from 0% (minimal disability) to 100% (maximum possible disability).
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): NCT01461005
|United States, California|
|University of California, Davis Medical Center|
|Sacramento, California, United States, 95816|
|Study Director:||Gitela Gandelman||Paradigm Spine LLC|