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Study to Investigate the Long Term Survivorship of Coflex

NCT02918669 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-02-24

Study results available
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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.

Conditions

  • Spinal Fractures

Interventions

RADIATION

CT Scan

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.

Sponsors & Collaborators

  • Paradigm Spine

    lead INDUSTRY

Principal Investigators

  • Hal Mathews, MD · Paradigm Spine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-05-26
Completion
2017-05-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02918669 on ClinicalTrials.gov