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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01461005
Recruitment Status : Terminated (FDA reclassified so all 522 studies were stopped,)
First Posted : October 27, 2011
Results First Posted : October 15, 2019
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Musculoskeletal Clinical Regulatory Advisers
Information provided by (Responsible Party):
Paradigm Spine

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
Allocation: N/A
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. Number of Participants Who Have an Incidence of Serious or Device Related Adverse Events Due to Device or Procedure. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Measurement of Lower Back Pain as Assessed by Visual Analog Scale [ Time Frame: 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)

  2. Measurement of Right Leg Pain as Assessed by Visual Analog Scale [ Time Frame: 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)

  3. Measurement of Left Leg Pain as Assessed by Visual Analog Scale [ Time Frame: 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)

  4. 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. [ Time Frame: 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".

  5. Assessment of Back Pain Using the Oswestry Low Back Pain Disability Index (ODI). [ Time Frame: 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461005


Locations
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United States, California
University of California, Davis Medical Center
Sacramento, California, United States, 95816
Sponsors and Collaborators
Paradigm Spine
Musculoskeletal Clinical Regulatory Advisers
Investigators
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Study Director: Gitela Gandelman Paradigm Spine LLC
More Information
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Responsible Party: Paradigm Spine
ClinicalTrials.gov Identifier: NCT01461005    
Other Study ID Numbers: Dynamic Stabilization System
First Posted: October 27, 2011    Key Record Dates
Results First Posted: October 15, 2019
Last Update Posted: February 19, 2020
Last Verified: February 2020
Keywords provided by Paradigm Spine:
Spondylolisthesis
Neurologic impairment
Kyphosis
Pseudarthrosis
Additional relevant MeSH terms:
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Spondylolisthesis
Kyphosis
Neurologic Manifestations
Pseudarthrosis
Spondylolysis
Spondylosis
Spinal Diseases
 Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Fractures, Ununited
Fractures, Bone
Wounds and Injuries
Nervous System Diseases