A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System

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.

NCT Number	NCT07118501
Lead Sponsor	Stryker Trauma and Extremities
Conditions	Post Traumatic Arthritis, Osteoarthritis, Total Ankle Replacement, Total Ankle Prosthesis
Enrollment	200 participants
Start Date	2026-02-06
Primary Completion	2030-09-30 (estimated)
Study Completion	2038-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-30