Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With TM-Ardis

Zimmer Biomet

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Degenerative Disc Disease

Interventions

TM- Ardis implant and Metal Reduction CT softwareDEVICE

TM- Ardis implant and Metal Reduction CT software

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.).

Locations (1)

St Alphonsus Regional Medical Center

Boise, Idaho, United States

Outcomes

Primary Outcomes

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

Time frame: 6 month post operative

Data from ClinicalTrials.gov

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