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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Spondylolisthesis; Neurologic Deficits; Kyphosis; Pseudarthrosis	Device: Dynamic Stabilization System (DSS)	Not Applicable

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)
Study Start Date :	September 2011
Actual Primary Completion Date :	September 2016
Actual Study Completion Date :	September 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Dynamic Stabilization System; Dynamic Stabilization System (DSS) System	Device: Dynamic Stabilization System (DSS); Dynamic Stabilization System

Outcome Measures

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Primary Outcome Measures :

1. The primary safety endpoint is to evaluate all Adverse Events of Dynamic Stabilization System (DSS) and fusion status. [ Time Frame: 2 years ]
   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 :

1. The VAS (visual analog scale), Oswestry Low Back Pain Disability (ODI) and EQ-5D outcomes questionnaires will be collected. [ Time Frame: 2 years ]
   The VAS, ODI and EQ-5D questionnaires will be collected to monitor the progress of patients receiving the DSS system.

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95816

Sponsors and Collaborators

Paradigm Spine

Musculoskeletal Clinical Regulatory Advisers

Investigators

Study Director:	Gitela Gandelman	Paradigm Spine LLC

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Paradigm Spine
ClinicalTrials.gov Identifier:	NCT01461005 History of Changes
Other Study ID Numbers:	Dynamic Stabilization System
First Posted:	October 27, 2011
Last Update Posted:	October 7, 2016
Last Verified:	October 2016

Keywords provided by Paradigm Spine:

Spondylolisthesis; Neurologic impairment; Kyphosis; Pseudarthrosis

Additional relevant MeSH terms:

Spondylolisthesis; Kyphosis; Pseudarthrosis; Neurologic Manifestations; Spondylolysis; Spondylosis; Spinal Diseases; Bone Diseases	Musculoskeletal Diseases; Spinal Curvatures; Fractures, Ununited; Fractures, Bone; Wounds and Injuries; Nervous System Diseases; Signs and Symptoms