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A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
Sponsor: Stryker Trauma and Extremities
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.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2026-02-06
Completion Date
2038-09-01
Last Updated
2026-03-24
Healthy Volunteers
No
Interventions
Total Ankle Replacement
Incompass™ Total Ankle System
Locations (4)
Illinois Bone and Joint Institute
Morton Grove, Illinois, United States
Baptist Health Louisville
Louisville, Kentucky, United States
Slocum Research & Education Foundation
Eugene, Oregon, United States
MUSC
Charleston, South Carolina, United States