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NCT02170558 Clinical Trial

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

Degenerative Disc Disease Clinical Trial

Official title:
Evaluating Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With Trabecular Metal Implants (TM-Ardis)

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02170558
Other study ID # CSU2013-05S
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date June 2014
Est. completion date December 2015

Study information
Verified date January 2019
Source Zimmer Biomet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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 information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• TM- Ardis implant and Metal Reduction CT software
TM- Ardis implant and Metal Reduction CT software

Locations
Country Name City State
United States St Alphonsus Regional Medical Center Boise Idaho

Sponsors (1)
Lead Sponsor Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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