Revision of failed total ankle replacement remains a challenge with limited information available to guide treatment options. I undertook a systematic review of electronic databases and other relevant sources to identify material relating to the incidence of revision after primary implantation of the Agility™ Total Ankle Replacement System. In an effort to procure the highest quality studies available, studies were eligible for inclusion only if they involved patients undergoing primary Agility™ Total Ankle Replacement; had evaluated patients at a mean follow-up of 12 months or longer; included details of the revision performed; and included revision etiologies of aseptic loosening, ballooning osteolysis, cystic changes, malalignment, or instability. A total of 14 studies involving 2312 ankles, with a weighted mean follow-up of 22.8 months, were included. Of the 2312 ankles, 224 (9.7%) underwent revision, of which 182 (81.3%) underwent implant component replacement, 34 (15.2%) underwent arthrodesis, and 8 (3.6%) underwent below-knee amputation. No significant effect from the surgeon’s learning curve on the incidence of revision or the type of revision surgery performed was identified. However, excluding the inventor increased the incidence of revision twofold, from 6.6% to 12.2%, and skewed the type of revision away from arthrodesis and toward implant component replacement or below-knee amputation. Regardless, the incidence of revision after primary implantation of the Agility™ Total Ankle Replacement System was less than historically reported and amenable to implant component revision more than 80% of the time. However, methodologically sound cohort studies are needed that include the outcomes after revision surgery, specifically focusing on what implant component replacement techniques are effective in enhancing survivorship of these revised implants and the role of custom-stemmed talar and tibial components have in revision of the Agility™ Total Ankle Replacement System. A direct comparison of the incidence of revision between the various contemporary total ankle replacement systems in common use is also warranted.
Level of Clinical Evidence: 4