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

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ClinicalTrials.gov Identifier: NCT02170558
Recruitment Status : Withdrawn
First Posted : June 23, 2014
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment
Degenerative Disc Disease Device: TM- Ardis implant and Metal Reduction CT software

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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating Enhanced Metal Reduction Techniques for Definitive CT Scanning to Assess Spinal Fusion With Trabecular Metal Implants (TM-Ardis)
Study Start Date : June 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02170558


Locations
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United States, Idaho
St Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Joel Batts Zimmer Biomet Spine

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT02170558     History of Changes
Other Study ID Numbers: CSU2013-05S
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Zimmer Biomet:
Trabecular Metal
Metal reduction CT
TM- Ardis

Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases