Study to Investigate the Long Term Survivorship of Coflex

Spinal Fractures Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02918669
• Other study ID #: PAS001a
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 26, 2017

Study information

• Verified date: February 2020
• Source: Paradigm Spine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 26, 2017
• Est. primary completion date: May 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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• Subjects who died, were withdrawn or withdrew consent to participate in the study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

Related Conditions & MeSH terms

• Spinal Fractures

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Paradigm Spine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan	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.	Post-60 Months