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 range21 Years
SexALL
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
âś“. 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)
âś“. Participants must be males or non-pregnant females aged 21 years or older at the time of surgery;
âś“. Willing and able to comply with the requirements of the clinical investigation plan (CIP), including attend all required study visits.
âś“. The participant must be able to follow instructions and deemed capable of completing clinical investigation questionnaires.
âś“. 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
âś•. Participant with an ankle condition, as determined by the investigator, to be an inappropriate candidate for total ankle replacement;
âś•. 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.
âś•. Participants who have participated previously in this clinical trial and who have been withdrawn.
âś•. Participant who is, or will be, inaccessible for follow-up
âś•. Participant is pregnant or intends to become pregnant during the course of the study.
âś•. Participants with a medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the clinical investigation.
âś•. Participants requiring revision total ankle replacement of the ankle being considered for the study;