An interventional study of Dynamic Stabilization System (DSS) in Spondylolisthesis, Neurologic Deficits and Kyphosis, sponsored by Paradigm Spine. Terminated at 1 site in United States. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-02-19.
Sponsored by Paradigm Spine · Not applicable, Interventional, and Treatment
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.
227 studies on the registry are indexed under Spondylolisthesis; 43 are open to participants now.
This study's enrollment of 1 is below the median of 60 across 143 interventional studies indexed under Spondylolisthesis.
Browse Spondylolisthesis studies →Paradigm Spine is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
| Milestone | Dynamic Stabilization System |
|---|---|
| Started | 1 |
| Completed | 0 |
| Not completed | 1 |
| Withdrew: Fda reclassified dynamic stabilization d | 1 |
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.
| Participants | Dynamic Stabilization System |
|---|---|
| Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure. | 0 |
Lower back pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
| units on a scale | Dynamic Stabilization System |
|---|---|
| Measurement of Lower Back Pain as Assessed by Visual Analog Scale | 2 |
Right leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
| units on a scale | DSS Stabilization System |
|---|---|
| Measurement of Right Leg Pain as Assessed by Visual Analog Scale | 2 |
Left leg pain as measured by the Visual Analog Scale (VAS) on the scale from 0 (no pain) to 100 (worst imaginable pain)
| units on a scale | DSS Stabilization System |
|---|---|
| Measurement of Left Leg Pain as Assessed by Visual Analog Scale | 12 |
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".
| participants | DSS Stabilization System |
|---|---|
| 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. | 1 |
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).
| score on a scale | DSS Stabilization System |
|---|---|
| Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI). | 2 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dynamic Stabilization System | — | 0/1 (0%) | 0/1 (0%) |
| Age, Continuous(years) | DSS Stabilization System |
|---|---|
| Mean | 67 ± 0 |
| Sex: Female, Male(Participants) | DSS Stabilization System |
|---|---|
| Female | 1 |
| Male | 0 |
| Region of Enrollment(Participants) | DSS Stabilization System |
|---|---|
| United States | 1 |
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Paradigm Spine