Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 1:15 AM
NCT ID:
NCT03063593
Eligibility Criteria:
Inclusion Criteria:
Subjects to be included in the study must meet all of the following criteria:
* Be 21 years of age at the time of surgery;
* Diagnosed with unilateral and/or bilateral ankle joint disease;
* Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis; Willing and able to consent to participate (written, informed consent / witnessed verbal consent) Willing and able to attend the requested follow-up visits;
* Subjects determined by the Investigator to be an appropriate candidate for the INFINITY® Total Ankle System
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
* Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement;
* Subjects requiring revision total ankle replacement of the ankle being considered for study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03063593
Study Brief:
Protocol Section:
NCT03063593