Study to Investigate the Long Term Survivorship of Coflex

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Spinal Fractures

Clinical Trial Details

NCT number	NCT02918669
Study type	Interventional
Source	Paradigm Spine
Contact
Status	Completed
Phase	N/A
Start date	April 2016
Completion date	May 26, 2017

View Details

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