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

NCT01461005 | Terminated Results

• 1 other identifier: Dynamic Stabilization System
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Spondylolisthesis; Neurologic Deficits; Kyphosis; Pseudarthrosis

Keywords

Spondylolisthesis; Neurologic impairment; Kyphosis; Pseudarthrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (5)

• Measurement of Lower Back Pain as Assessed by Visual Analog Scale

  6 months

• Measurement of Right Leg Pain as Assessed by Visual Analog Scale

  6 months

• Measurement of Left Leg Pain as Assessed by Visual Analog Scale

  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.

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

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

  6 months

Study Arms (1)

Dynamic Stabilization System

EXPERIMENTAL

Dynamic Stabilization System (DSS) System

Device: Dynamic Stabilization System (DSS)

Interventions

Dynamic Stabilization System (DSS) DEVICE

Dynamic Stabilization System

Dynamic Stabilization System

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Paradigm Spine: lead
• MCRA: collaborator

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95816, United States

Location

MeSH Terms

Conditions

Spondylolisthesis; Neurologic Manifestations; Kyphosis; Pseudarthrosis

Condition Hierarchy (Ancestors)

Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Curvatures; Fractures, Ununited; Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Justin Eggleton, Senior Director, Spine Regulatory Affairs
• Organization: MCRA

jeggleston@mcra.com

2025525804

Study Officials

• Gitela Gandelman

  Paradigm Spine LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: October 27, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 19, 2020
• Results First Posted: October 15, 2019

Record last verified: 2020-02

Locations

US (1)