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

Primary Purpose

Spondylolisthesis, Neurologic Deficits, Kyphosis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dynamic Stabilization System (DSS)

About this trial

This is an interventional treatment trial for Spondylolisthesis focused on measuring Spondylolisthesis, Neurologic impairment, Kyphosis, Pseudarthrosis

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patient is skeletally mature (21-85 years old).
Patient has degenerative spondylolisthesis (Grade 1-3) with objective evidence of neurologic impairment, kyphosis, and/or failed previous fusion (pseudarthrosis) at index level.
Capable and willing to comply with the requirements unique to the study, adhere to the post-operative treatment and management program, and return for required follow-up examinations.
Surgeon has determined that DSS™ System is an appropriate treatment for the patient without regard to the study.

Exclusion Criteria:

The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications.
Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general.
Acute or chronic systemic, spinal or localized infections.
Active, severe systemic and metabolic diseases.
Obesity defined as Body Mass Index > 35.
Subject is pregnant or interested in becoming pregnant in the next 36 months.
Dependency on pharmaceutical drugs, drug abuse, or alcoholism.
Lack of patient cooperation.
Foreign body sensitivity to the implant material.
Degenerative scoliosis greater than 25 degrees.
Grade 4 degenerative spondylolisthesis (>75% slip).
Significant osteopenia A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia).
Soft tissue deficit not allowing wound closure.
Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device.
Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae.
Bony lumbar spinal stenosis not related to the primary degenerative spondylolisthesis indication.
Pars defect.
Clinically compromised vertebral bodies at affected level due to current or past trauma.
Prisoner or ward of the state.
Currently in litigation regarding a spinal condition.
Known allergy to titanium, titanium alloys, CoCrMo, polyethylene or MR contrast agents.
Is currently involved in a study of another investigational product for similar purpose.

Sites / Locations

University of California, Davis Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dynamic Stabilization System

Arm Description

Dynamic Stabilization System (DSS) System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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)

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)

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".

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).

Full Information

NCT ID

NCT01461005

First Posted

October 18, 2011

Last Updated

February 6, 2020

Sponsor

Paradigm Spine

Collaborators

MCRA

1. Study Identification

Unique Protocol Identification Number

NCT01461005

Brief Title

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

Acronym

DSS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Why Stopped

FDA reclassified so all 522 studies were stopped,

Study Start Date

September 2011 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Paradigm Spine

Collaborators

MCRA

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the Post-Market Surveillance study is to evaluate safety.

Detailed Description

Paradigm Spine Dynamic Stabilization System (DSS) study is a prospective, multi-center, literature controlled study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis

Keywords

Spondylolisthesis, Neurologic impairment, Kyphosis, Pseudarthrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dynamic Stabilization System

Arm Type

Experimental

Arm Description

Dynamic Stabilization System (DSS) System

Intervention Type

Device

Intervention Name(s)

Dynamic Stabilization System (DSS)

Intervention Description

Dynamic Stabilization System

Primary Outcome Measure Information:

Title

Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure.

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Measurement of Lower Back Pain as Assessed by Visual Analog Scale

Description

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

Title

Measurement of Right Leg Pain as Assessed by Visual Analog Scale

Description

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

Title

Measurement of Left Leg Pain as Assessed by Visual Analog Scale

Description

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

Title

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.

Description

Time Frame

Pre-Op, 6 weeks, 6 months, 12 months, and 24 months

Title

Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI).

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient is skeletally mature (21-85 years old). Patient has degenerative spondylolisthesis (Grade 1-3) with objective evidence of neurologic impairment, kyphosis, and/or failed previous fusion (pseudarthrosis) at index level. Capable and willing to comply with the requirements unique to the study, adhere to the post-operative treatment and management program, and return for required follow-up examinations. Surgeon has determined that DSS™ System is an appropriate treatment for the patient without regard to the study. Exclusion Criteria: The need for interbody cages, allograft, or any other assistance during surgery. Device is only to be used with autograft per FDA approved indications. Any medical, mental or surgical condition precluding the potential benefit of spinal surgery or surgery in general. Acute or chronic systemic, spinal or localized infections. Active, severe systemic and metabolic diseases. Obesity defined as Body Mass Index > 35. Subject is pregnant or interested in becoming pregnant in the next 36 months. Dependency on pharmaceutical drugs, drug abuse, or alcoholism. Lack of patient cooperation. Foreign body sensitivity to the implant material. Degenerative scoliosis greater than 25 degrees. Grade 4 degenerative spondylolisthesis (>75% slip). Significant osteopenia A screening questionnaire for osteopenia, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients who require a DEXA bone mineral density measurement. If DEXA is required*, exclusion will be defined as a DEXA bone density measured T score of ≤ -1.0 (The World Health Organization definition of osteopenia). Soft tissue deficit not allowing wound closure. Congenital abnormalities, tumors or other conditions that would prevent secure component fixation that has the potential to decrease the useful life of the device. Inadequate pedicles or vertebral body geometry of the thoracic, lumbar and sacral vertebrae. Bony lumbar spinal stenosis not related to the primary degenerative spondylolisthesis indication. Pars defect. Clinically compromised vertebral bodies at affected level due to current or past trauma. Prisoner or ward of the state. Currently in litigation regarding a spinal condition. Known allergy to titanium, titanium alloys, CoCrMo, polyethylene or MR contrast agents. Is currently involved in a study of another investigational product for similar purpose.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gitela Gandelman

Organizational Affiliation

Paradigm Spine LLC

Official's Role

Study Director

Facility Information:

Facility Name

University of California, Davis Medical Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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