Study to Investigate the Long Term Survivorship of Coflex

NCT02918669 | Completed Results

• 1 other identifier: PAS001a
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Fractures

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

coflex

EXPERIMENTAL

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.

Radiation: CT Scan

Interventions

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.

coflex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects who died, were withdrawn or withdrew consent to participate in the study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

Sponsors & Collaborators

• Paradigm Spine: lead

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Fran Magee, DVM
• Organization: Paradigm Spine

fran.magee@paradigmspine.com

212-367-7274

Study Officials

• Hal Mathews, MD

  Paradigm Spine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: September 29, 2016
• Study Start: April 1, 2016
• Primary Completion: May 26, 2017
• Study Completion: May 26, 2017
• Last Updated: February 24, 2020
• Results First Posted: July 8, 2019

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share