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RECRUITING
NCT07118501

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

Sponsor: Stryker Trauma and Extremities

View on ClinicalTrials.gov

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

DEVICE

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