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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients implanted w/TM-Ardis | Patients who are receiving a TM-Ardis implant for degenerative disc disease will have a CT scan immediate post op (2 weeks) and again at 6 months to determine if fusion can be assessed with the study metal reduction software. Will utilize TM- Ardis implant and Metal Reduction CT software |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TM- Ardis implant and Metal Reduction CT software | Device | TM- Ardis implant and Metal Reduction CT software |
|
| Measure | Description | Time Frame |
|---|---|---|
| CT scan to determine if the study software can reduce metal scatter on the scan. | 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 | 6 month post operative |
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Inclusion Criteria:
Exclusion Criteria:
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All patients who are having a spinal fusion procedure with TM-Ardis and meet the requirements below are eligible for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Joel Batts | Zimmer Biomet Spine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Alphonsus Regional Medical Center | Boise | Idaho | 83706 | United States |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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