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

Withdrawn

• Conditions: Degenerative Disc Disease
• Interventions: Device: TM- Ardis implant and Metal Reduction CT software

• 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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-23
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Patients implanted w/TM-Ardis	TM- Ardis implant and Metal Reduction CT software	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

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

Trial Locations

Locations (1)

St Alphonsus Regional Medical Center; 🇺🇸 Boise, Idaho, United States