Study to Investigate the Long Term Survivorship of Coflex

Not Applicable

Completed

• Conditions: Spinal Fractures
• Interventions: Radiation: CT Scan

• Registration Number: NCT02918669
• Lead Sponsor: Paradigm Spine

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-29
• Primary Completion: 2017-05-26
• Study Completion: 2017-05-26
• Results First Submitted: 2018-10-15
• Results First Submitted QC: 2019-06-11
• Results First Posted: 2019-07-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-20
• Last Update Posted: 2020-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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• Subjects who died, were withdrawn or withdrew consent to participate in the study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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
coflex	CT Scan	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan	Post-60 Months	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.