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

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

Full Title of Study: “Evaluating Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With Trabecular Metal Implants (TM-Ardis)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2015

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.

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • CT scan to determine if the study software can reduce metal scatter on the scan.
    • Time Frame: 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

Participating in This Clinical Trial

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.).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zimmer Biomet
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joel Batts, Study Director, Zimmer Biomet Spine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.