Abstract

Study design:Case Report Objective:The objective of this study was to evaluate the performance of the Amedica - TL fusion device in two patients with a history of posterior lumbar interbody spinal fusion. Methods:Two patients who underwent a TLIF procedure with posterior spinal instrumentation using the Valeo® ceramic interbody TLIF implant were reviewed. At 1-year follow up, clinical and radiographic outcomes using CT scans and dynamic x-rays were evaluated. Results:CT scans and dynamic x-rays at one year demonstrated solid interbody fusion and solid posterolateral fusion in both patients. Bone appeared to be well formed to the Valeo® implant as well as through and behind the implant in the interbody space. Additionally, there was no evidence of subsidence, migration or implant fracture/failure. Conclusions:Solid bony fusion was demonstrated on dynamic x-rays and CT scans at 1-year follow up, which may be due to the proprietary nature of the ceramic that promotes bony growth on the implant as well as through the implant, and the better imaging compatibility of the Valeo® ceramic implant. These preliminary results suggest that Valeo® may be an appealing substitute for use in a TLIF procedure instead of a standard titanium, PEEK or carbon fiber graft. Well-designed studies with large sample sizes are needed to confirm the capabilities and performance of the Valeo® ceramic implant.

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