Incompass™ Total Ankle System Study for Ankle Arthritis
This study is looking at the safety and performance of the Incompass™ Total Ankle System, which is a device used in total ankle replacement surgery. This system has already been approved by the FDA and is routinely used. The study aims to see how well patients recover and how their quality of life and pain improve after surgery with this device. Researchers will review your routine medical images, like X-rays and CT scans, to understand how the device is working. You may be able to join if you are 21 years or older and are having total ankle replacement surgery. The main goal is to measure improvements in your ankle osteoarthritis (arthritis) symptoms over time.
- Study design
- This is an observational study that plans to include 200 participants. It follows the standard care you would receive after total ankle replacement surgery.
- What's involved
- You would have your routine medical images (X-rays and CT scans) reviewed. You would also complete questionnaires about your ankle osteoarthritis at several time points over 10 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 10 years after their surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
At a glance
Conditions
Where it's being run
5 sites across 5 statesStudy leadership
- Rebecca Gibson · STUDY_DIRECTOR · Stryker Trauma & Extremities
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Ankle Osteoarthritis Scale (AOS)Baseline, 6 month, 1 Year, 2 Year, 5 Year, 7 Year, 10 Year
The AOS questionnaire consists of two 9-item subscales: one for pain and one for disability. Each subscale uses a visual analogue scale where patients mark a point on a 100mm horizontal line anchored by "No pain" and "Worst pain imaginable" for pain, or "No difficulty" and "So difficult unable" for disability