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:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT06193057
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement.
* Consenting patients and able to complete scheduled study procedures and follow-up evaluations.
* Patients who have signed the "informed consent" approved by the Ethics Committee.
Exclusion Criteria:
* Social conditions (homeless patients, with restrictions on personal freedom)
* ASA 3 and 4
* Deep venous insufficiency Lower limbs
* History of Erisipelas lower limbs
* Neurological or psychocognitive disorders
* neurological diseases
* Axial deformities of ankle \>15°
* Personal or family history of DVT or EP
* Prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis)
* Pregnant women
* Patients with rheumatic diseases
* Patients that requires ancillary surgical procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT06193057
Study Brief:
Protocol Section:
NCT06193057