Study to Investigate the Long Term Survivorship of Coflex

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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Key information

Conditions

Spinal Fractures Back Injuries Fractures, Bone Spinal Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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Subjects who died, were withdrawn or withdrew consent to participate in the study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

Treatment and study plan

CT Scan

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.

Primary outcomes

Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Paradigm Spine

Industry

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Sep 29, 2016
Registry last updated: Feb 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed