A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
brief summary
The goal of this study is to demonstrate the safety and performance of the Incompass™ Total Ankle System after surgery over the standard follow-up period. The study will measure improvements in patient-reported information related to quality of life and pain following surgery. In order to do this, medical imaging (i.e. X-Rays, CT scans) which have been taken as part of routine care, will be reviewed. Any additional X-Rays conducted during the period of the research will also be reviewed. The Incompass™ Total Ankle System has been cleared by the Food and Drug Administration (FDA). The products are already in use routinely in ankle replacement surgeries. No part of this study is experimental.
detailed description
It is anticipated that a total of 200 subjects will be enrolled at up to ten sites over a three year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with a total ankle replacement including imaging (x-rays and or CT scans).
The primary endpoint of this study is the 24-month total Ankle Osteoarthritis Scale (AOS) score improvement after index surgery (or Initial Assessment). Secondary endpoints include safety (adverse events, reoperation, and survivorship) as well as performance measures (radiographic assessments, PROMIS Global Health questionnaire, Foot and Ankle Ability Measure \[FAAM\] and Total Ankle Replacement \[TAR\] Satisfaction questionnaires).