Trial Outcomes & Findings for A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS) (NCT NCT01461005)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2020-02-19

Participant Flow

Participant milestones

Participant milestones
Measure	Dynamic Stabilization System Dynamic Stabilization System (DSS) System Dynamic Stabilization System (DSS): Dynamic Stabilization System
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Dynamic Stabilization System Dynamic Stabilization System (DSS) System Dynamic Stabilization System (DSS): Dynamic Stabilization System
Overall Study FDA reclassified Dynamic Stabilization D	1

Baseline Characteristics

A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DSS Stabilization System n=1 Participants DSS Stabilization System
Age, Continuous	67 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Dynamic Stabilization System n=1 Participants Dynamic Stabilization System (DSS) System 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.	0 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Dynamic Stabilization System n=1 Participants Dynamic Stabilization System (DSS) System Dynamic Stabilization System (DSS): Dynamic Stabilization System
Measurement of Lower Back Pain as Assessed by Visual Analog Scale	2 units on a scale

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Dynamic Stabilization System n=1 Participants Dynamic Stabilization System (DSS) System Dynamic Stabilization System (DSS): Dynamic Stabilization System
Measurement of Right Leg Pain as Assessed by Visual Analog Scale	2 units on a scale

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Dynamic Stabilization System n=1 Participants Dynamic Stabilization System (DSS) System Dynamic Stabilization System (DSS): Dynamic Stabilization System
Measurement of Left Leg Pain as Assessed by Visual Analog Scale	12 units on a scale

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Dynamic Stabilization System n=1 Participants Dynamic Stabilization System (DSS) System Dynamic Stabilization System (DSS): Dynamic 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 participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Dynamic Stabilization System n=1 Participants Dynamic Stabilization System (DSS) System Dynamic Stabilization System (DSS): Dynamic Stabilization System
Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI).	2 score on a scale

Adverse Events

Dynamic Stabilization System

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

Justin Eggleton, Senior Director, Spine Regulatory Affairs

MCRA

Phone: 2025525804

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60