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

January 22, 2019 updated by: Zimmer Biomet

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Idaho
      • Boise, Idaho, United States, 83706
        • St Alphonsus Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients who are having a spinal fusion procedure with TM-Ardis and meet the requirements below are eligible for this study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: TM- Ardis implant and Metal Reduction CT software
TM- Ardis implant and Metal Reduction CT software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 month post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Joel Batts, Zimmer Biomet Spine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSU2013-05S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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