NCT02918669

Study to Investigate the Long Term Survivorship of Coflex

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Paradigm Spine · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Fractures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-05-26
• Completion: 2017-05-26
• First posted: 2016-09-29
• Last updated: 2020-02-24
• Results posted: 2019-07-08