Degenerative Disc Disease
Conditions
Keywords
Trabecular Metal, Metal reduction CT, TM- Ardis
Brief summary
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability. Assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant
Detailed description
To determine if the subject metal reduction software helps to better visualize bone interphase and fusion reliability, and assess whether the appropriate procedural modification facilitates clearer images when implanted with a trabecular metal spinal implant.
Interventions
DEVICETM- Ardis implant and Metal Reduction CT software
TM- Ardis implant and Metal Reduction CT software
Sponsors
Zimmer Biomet
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* A signed informed consent. * Male or non-pregnant female scheduled for Trabecular Metal (TM - Ardis) implant, single level lumbar. * Participant must be at least 18 years of age.
Exclusion criteria
* Patient is pregnant Patient is unable to comprehend the requirements of the study. * Patient is unable to undergo scanning (due to body habitus, inability to comply with positioning requirements, etc.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CT scan to determine if the study software can reduce metal scatter on the scan. | 6 month post operative | Each CT scan will be evaluated to asses if you can visualize fusion, bone interface, and/or device migration with an experimental metal reduction software for CT scan |
Countries
United States
Outcome results
None listed