The purpose of the Post-Market Surveillance study is to evaluate safety.
Paradigm Spine Dynamic Stabilization System (DSS) study is a prospective, multi-center, literature controlled study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Dynamic Stabilization System
University of California, Davis Medical Center
Sacramento, California, United States
Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure.
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.
Time frame: 6 months
Measurement of Lower Back Pain as Assessed by Visual Analog Scale
Lower back pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Time frame: 6 months
Measurement of Right Leg Pain as Assessed by Visual Analog Scale
Right leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Time frame: 6 months
Measurement of Left Leg Pain as Assessed by Visual Analog Scale
Left leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
Time frame: 6 months
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.
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".
Time frame: Pre-Op, 6 weeks, 6 months, 12 months, and 24 months
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Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI).
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).
Time frame: 6 months