Quality Assessment of Modern Total Ankle Arthroplasty Clinical Outcomes Research.

Abstract

Research demonstrating improved outcomes with third-generation ankle replacement implants has resulted in increasing utilization of total ankle arthroplasty over the past 3 decades. The purpose of this study was to examine the quality and trends of clinical outcomes research being published on third-generation total ankle arthroplasty implants. Two fellowship-trained foot and ankle surgeons reviewed all peer-reviewed, Medline-indexed English-language clinical outcomes studies evaluating total ankle arthroplasty published between 2006 and 2019. Articles were assessed for study design and indicators of study quality. A total of 694 published articles were reviewed and 231 met all inclusion criteria. The majority (78%) of studies were retrospective, most of which were case series (54%) or cohorts (32%). Ten percent (10%) of studies were funded by industry and 28% did not disclose funding sources. Thirty-eight percent (38%) of studies reported a conflict of interest and 6% did not disclose whether or not there were conflicts. The average patient follow-up time across studies was 72 months. We found that although the study of outcomes with third-generation total ankle arthroplasty prostheses is steadily increasing, most studies are Level IV, retrospective case series. Some studies have disclosed industry funding and/or a conflict of interest, and a considerable number did not disclose potential funding and/or financial conflicts. Future investigators should strive to design studies with the highest quality methodology possible.