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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT06941558
Eligibility Criteria:
Inclusion Criteria:
1. Male or non-pregnant female over the age of 21 years with a diagnosis of end stage ankle arthritis and requiring primary TAA/TAR and is suitable for the use of the ADAPTIS TAA/TAR
2. Patients who are physically and mentally willing and able to comply with the post-operative follow-ups and an appropriate rehabilitation schedule.
3. Patient can understand and provide written consent.
Exclusion Criteria:
1. Patients with previous ankle arthrodesis or Patients who require revision of previously implanted TAA/TAR.
2. Any patients presenting with clinically relevant conditions prior to implantation, that would contraindicate implantation of a TAA/TAR
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06941558
Study Brief:
Protocol Section:
NCT06941558