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 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 12:21 AM
NCT ID:
NCT05729958
Eligibility Criteria:
Inclusion Criteria:
* Patient can understand the study's meaning and is willing to sign the study-specific Informed Patient Consent Form.
* Patient received the implantation of Infinity or Inbone prosthesis using PROPHECY PSI for primary TAR in 2022.
* There are at least 3 months of follow-up data for this patient.
* Patient can lay still during the length of duration of the CT-scan.
Exclusion Criteria:
* If per-operative the use of the PSI guides was abandoned.
* Patients that underwent revision surgery (defined as original tibia of talar component change or removal).
* Patients that endured other diseases that significantly impacted the post-operative period following TAR (e.g. amputation, severe extremity dysfunction due to a neurological or vascular impairment or trauma).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT05729958
Study Brief:
Protocol Section:
NCT05729958