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

Brief Summary

Official Title: “A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)”

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

  • Study Type: Interventional
  • Study Design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: July 2014

Detailed Clinical Trial Description

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

Interventions Used in this Clinical Trial

  • Device: Dynamic Stabilization System (DSS)
    • Dynamic Stabilization System

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Dynamic Stabilization System
    • Dynamic Stabilization System (DSS) System

Outcome Measures for this Clinical Trial

Primary Measures

  • The primary safety endpoint is to evaluate all Adverse Events of Dynamic Stabilization System (DSS) and fusion status.
    • Time Frame: 2 years
      Safety Issue?: Yes

Secondary Measures

  • The VAS (visual analog scale), Oswestry Low Back Pain Disability (ODI) and EQ-5D outcomes questionnaires will be collected.
    • Time Frame: 2 years
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Paradigm Spine
  • Collaborator
    • Musculoskeletal Clinical Regulatory Advisers LLC
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Gitela Gandelman, Study Director, Paradigm Spine LLC
  • Overall Contact(s)
    • Gitela Gandelman, 212-583-9700, ggandelman@vbllc.com

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01461005