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

NCT07118501 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2026-03-24

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Total Ankle Replacement

Incompass™ Total Ankle System

Sponsors & Collaborators

  • Stryker Trauma and Extremities

    lead INDUSTRY

Principal Investigators

  • Rebecca Gibson · Stryker Trauma & Extremities

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2030-09-30
Completion
2038-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07118501 on ClinicalTrials.gov