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

NCT02170558 | Withdrawn

• 1 other identifier: CSU2013-05S
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Degenerative Disc Disease

Keywords

Trabecular Metal; Metal reduction CT; TM- Ardis

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (1)

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

Interventions

TM- Ardis implant and Metal Reduction CT software DEVICE

TM- Ardis implant and Metal Reduction CT software

Patients implanted w/TM-Ardis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

St Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Joel Batts

  Zimmer Biomet Spine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

US (1)