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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Paradigm Spine
Sponsor:
Collaborator:
Musculoskeletal Clinical Regulatory Advisers LLC
Information provided by (Responsible Party):
Paradigm Spine
ClinicalTrials.gov Identifier:
NCT01461005
First received: October 18, 2011
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Spondylolisthesis
Neurologic Deficits
Kyphosis
Pseudarthrosis
Device: Dynamic Stabilization System (DSS)

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)

Further study details as provided by Paradigm Spine:

Primary Outcome Measures:
  • The primary safety endpoint is to evaluate all Adverse Events of Dynamic Stabilization System (DSS) and fusion status. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    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:
  • The VAS (visual analog scale), Oswestry Low Back Pain Disability (ODI) and EQ-5D outcomes questionnaires will be collected. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    The VAS, ODI and EQ-5D questionnaires will be collected to monitor the progress of patients receiving the DSS system.


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dynamic Stabilization System
Dynamic Stabilization System (DSS) System
Device: Dynamic Stabilization System (DSS)
Dynamic Stabilization System
Other Name: Dynamic Stabilization System (DSS)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461005

Contacts
Contact: Gitela Gandelman 212-583-9700 ggandelman@vbllc.com
Contact: Abigail Allen 202-552-5800 aallen@mcra.com

Locations
United States, California
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95816
Contact: Martha Robinson, CCRP    916-734-3660    martha.robinson@ucdmc.ucdavis.edu   
Principal Investigator: Rolando F. Roberto, MD         
United States, Colorado
The Spine Center-Loveland Recruiting
Loveland, Colorado, United States, 80538
Principal Investigator: Kenneth A Pettine, MD         
Sponsors and Collaborators
Paradigm Spine
Musculoskeletal Clinical Regulatory Advisers LLC
Investigators
Study Director: Gitela Gandelman Paradigm Spine LLC
  More Information

No publications provided

Responsible Party: Paradigm Spine
ClinicalTrials.gov Identifier: NCT01461005     History of Changes
Other Study ID Numbers: Dynamic Stabilization System
Study First Received: October 18, 2011
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Paradigm Spine:
Spondylolisthesis
Neurologic impairment
Kyphosis
Pseudarthrosis

Additional relevant MeSH terms:
Spondylolisthesis
Kyphosis
Pseudarthrosis
Spondylolysis
Spondylosis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Fractures, Ununited
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014