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AxioMed Research
Investigational Device Exemption (IDE) Lumbar Clinical Trial
Prospective, Multi-center, Randomized, Controlled IDE Clinical Trial: Freedom Lumbar Disc (FLD) One-Level IDE Pivotal Study in the Treatment of Lumbar Degenerative Disc Disease completed in 2015
The Freedom Lumbar Disc is indicated for spinal arthroplasty in skeletally mature patients with single level, symptomatic degenerative disc disease (DDD) from L3-S1. This was a prospective, multi-center, randomized, controlled trial. 300 patients with DDD was randomized to disc arthroplasty with the FLD device or the ProDisc (control device). The overall purpose (objective) of this trial was to collect clinical data to demonstrate the safety and effectiveness of FLD used for the treatment of symptomatic lumbar degenerative disc disease compared to the control device.
AxioMed Studies
Kingsley R. Chin^, Jacob Ryan Lubinski, Kari Bracher Zimmers, Barry Eugene Sands, Fabio Pencle
The Freedom Cervical Disc (FCD) performs as expected in patients with single-level and two-level degenerative disc disease. In this early clinical experience with the FCD, patients experienced similar pain relief and lower disability at 2 years follow-up compared to both articulating and viscoelastic TDRs
Research Abstracts
AxioMed Studies
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Pending.
Two-Year Prospective Analysis of AxioMed Cervical Viscoelastic Total Disc Replacement: Clinical Efficacy and Radiographic Outcome Comparisons in a Jamaican and European Population: A Pilot Study
Kingsley R Chin, Vito Lore, Erik Spayde, William M Spayde, Hope Estevez, Marilyn Speid, Chukwunonso C Ilogu, Jason A Seale
Lateral Viscoelastic Disc Studies
Dr. Kingsley R Chin (left) and Dr. Luiz Pimenta (right), inventor of the extreme lateral lumbar fusion (XLIF) approach for Nuvasive, at SMISS 2024
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