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

Zimmer Biomet

Status: Withdrawn

Conditions: Degenerative Disc Disease

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02170558

CSU2013-05S

Details and patient eligibility

About

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 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

0 participants in 1 patient group

Patients implanted w/TM-Ardis

Description:

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

Treatment:

Device: TM- Ardis implant and Metal Reduction CT software