Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With TM-Ardis
Withdrawn
- Conditions
- Degenerative Disc Disease
- Registration Number
- NCT02170558
- Lead Sponsor
- Zimmer Biomet
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
St Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
St Alphonsus Regional Medical Center🇺🇸Boise, Idaho, United States