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Study to Investigate the Long Term Survivorship of Coflex

Primary Purpose

Spinal Fractures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CT Scan
Sponsored by
Paradigm Spine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spinal Fractures

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant in coflex IDE Study
  • Willing and able to give informed consent
  • Spinous process fracture identified by site and/or radiographic lab at 24 months

Exclusion Criteria:

  • Subjects who died, were withdrawn or withdrew consent to participate in the study
  • Subjects who are pregnant, or planning to become pregnant, during the course of this study
  • Subjects who have cancer, whether active or in remission

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    coflex

    Arm Description

    Patients who received the coflex Device in the IDE Study and presented with a spinous process fracture at 24 months (identified by independent radiographic review lab). Patients will undergo a CT Scan.

    Outcomes

    Primary Outcome Measures

    Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan
    Any coflex patients with radiographic observations of spinous process fracture at post-24 months, will be examined via CT at 5 years for evidence of fracture or of healing.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 27, 2016
    Last Updated
    February 20, 2020
    Sponsor
    Paradigm Spine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02918669
    Brief Title
    Study to Investigate the Long Term Survivorship of Coflex
    Official Title
    Study to Investigate the Long Term Survivorship of Coflex CT Study: Sub-Analysis of 24 Month Spinous Process Fractures Via Post-60 Month CT Scan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    May 26, 2017 (Actual)
    Study Completion Date
    May 26, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Paradigm Spine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Examine the long-term survivorship via CT Scan of the coflex in patients who presented with spinous process fracture(s) at 24 months in the Paradigm Spine coflex IDE Study.
    Detailed Description
    This is a prospective, multi-center, single-arm, radiographic evaluation of all coflex IDE patients who presented with a spinous process fracture at 24 months as identified by independent radiographic review (using X-ray or CT). All patients were enrolled and followed through 60 months under the IDE and extended follow-up protocol. The specific objective of this CT Study is to perform a sub-analysis of the patients with 24 month spinous process fracture(s) via a CT scan at post-60 months. A CT Scan will be performed and analyzed by an independent radiographic review lab for evidence of fracture or healing at the long term timepoint.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Fractures

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    coflex
    Arm Type
    Experimental
    Arm Description
    Patients who received the coflex Device in the IDE Study and presented with a spinous process fracture at 24 months (identified by independent radiographic review lab). Patients will undergo a CT Scan.
    Intervention Type
    Radiation
    Intervention Name(s)
    CT Scan
    Intervention Description
    Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months. There are no other interventions. It is just a onetime CT post 60 month time point.
    Primary Outcome Measure Information:
    Title
    Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan
    Description
    Any coflex patients with radiographic observations of spinous process fracture at post-24 months, will be examined via CT at 5 years for evidence of fracture or of healing.
    Time Frame
    Post-60 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participant in coflex IDE Study Willing and able to give informed consent Spinous process fracture identified by site and/or radiographic lab at 24 months Exclusion Criteria: Subjects who died, were withdrawn or withdrew consent to participate in the study Subjects who are pregnant, or planning to become pregnant, during the course of this study Subjects who have cancer, whether active or in remission
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hal Mathews, MD
    Organizational Affiliation
    Paradigm Spine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study to Investigate the Long Term Survivorship of Coflex

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