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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

TM- Ardis implant and Metal Reduction CT software

Intervention Type DEVICE

TM- Ardis implant and Metal Reduction CT software

Interventions

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TM- Ardis implant and Metal Reduction CT software

Intervention Type DEVICE

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No