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

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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Post Traumatic Arthritis
• Osteoarthritis
• Total Ankle Replacement
• Total Ankle Prosthesis

Eligibility basics and study details

Study type

Observational

Phase

Not applicable

Ages

21 years and older

Sex

All

Healthy volunteers

Not accepted

Sponsor

Stryker Trauma and Extremities

Last updated on ClinicalTrials.gov

August 24, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites