Charles Saltzman, newly-elected president of the American Orthopaedic Foot & Ankle Society (AOFAS), presented the results of a study at the recent AOFAS 2009 annual summer meeting in Vancouver, British Columbia, Canada.
The 24 month non-randomised clinical trial was conducted at 15 medical institutions offering a broad spectrum of surgical experience.
After 24 months, reportedly, the ankles treated with Scandinavian Total Ankle Replacement (STAR) ankle replacement had better function and equivalent pain relief as ankles treated with ankle fusion surgery. The study was published in the July 2009 issue of the Foot & Ankle International (FAI), the official journal of the AOFAS.
The company said that the STAR is an uncemented, mobile-bearing total ankle replacement (TAR) device which is new in the US.
The goal of this study was to perform an evaluation of the safety and efficacy of a mobile-bearing prosthesis to treat end-stage ankle arthritis, and was approved as part of the investigational device exemption (IDE) by the Food and Drug Administration (FDA).
The pivotal study design was a non-inferiority study with ankle fusion as the control. Three groups of patients were used in the study: a group of 158 STAR total ankle patients and a control group of 66 ankle fusion patients (the Pivotal Study Groups) and a second group of 448 STAR patients (Continued Access Group), whose surgery was performed following the completion of enrollment in the Pivotal Study, the company said.
Results were reported up to 24 months following surgery. Complete data at 24 months was available for 96% of the pivotal ankle replacements, 79% of the pivotal ankle fusions and 66% of the continued access ankle replacements.
By the end of the 24 months, ankles treated with the STAR ankle replacement had better function and equivalent pain relief as ankles treated with fusion.