N/A
N=12
Study to Investigate the Long Term Survivorship of Coflex
Spinal Fractures
Bottom Line
View on ClinicalTrials.gov: NCT02918669 ↗Enrolled (actual)
12
Serious AEs
—
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan — 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CT Scan (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Paradigm Spine
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Radiographic Analysis of Evidence of Fracture or Healing Based on CT Scan |
8 | — |
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.
Eligibility Criteria
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- Subjects who died, were withdrawn or withdrew consent to participate in the study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
Data sourced from ClinicalTrials.gov (NCT02918669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.