Study to Investigate the Long Term Survivorship of Coflex

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-05-26

Brief Summary

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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.

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Detailed Description

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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

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Spinal Fractures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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coflex

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.

Group Type EXPERIMENTAL

CT Scan

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No