A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System (NCT07118501) | Clinical Trial Compass
RecruitingNot Applicable
A Prospective, Post-Market, Clinical Follow-up Study of the Incompass™ Total Ankle System
United States200 participantsStarted 2026-02-06
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The participant must be willing and able to sign a written approved informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC)
. Participants must be males or non-pregnant females aged 21 years or older at the time of surgery;
. Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits.
. The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires.
. Considered a candidate for total ankle replacement with the Incompass Total Ankle System in accordance with its legally approved Indication for Use (IFU).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement;
. Participant is currently enrolled in or plans to enroll in any concurrent drug and/or device clinical investigation that, in the opinion of the Investigator, may confound results;
. Any participant that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44.
. Participants who have participated previously in this clinical trial and who have been withdrawn.
. Participant who is, or will be, inaccessible for follow-up
. Participant is pregnant or intends to become pregnant during the course of the study.
. Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation.
. Participants requiring revision total ankle replacement of the ankle being considered for the study;