Study to Investigate the Long Term Survivorship of Coflex

Paradigm Spine

Status: Completed

Conditions: Spinal Fractures

Treatments: Radiation: CT Scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT02918669

PAS001a

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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• Subjects who died, were withdrawn or withdrew consent to participate in the study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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

coflex

Experimental group

Description:

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.

Treatment:

Radiation: CT Scan