Comparison of Customized and Standard Total Ankle Prostheses

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Dec 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two types of total ankle replacement (TAR) surgeries for patients with ankle osteoarthritis. One type uses a standard procedure, while the other involves a customized approach where the prosthesis (the artificial joint) is specially made to fit each patient's ankle based on detailed imaging scans. The goal is to see which method leads to better healing, less pain, and overall satisfaction for the patients, as well as to compare the costs of both procedures.

To be eligible for this study, participants must be between 40 and 75 years old and have ankle arthritis that requires surgery. They should be able to understand the study and agree to participate by signing a consent form. However, certain conditions might prevent someone from joining, such as severe health issues, previous surgeries on other joints, or being pregnant. Participants in the trial can expect to undergo surgery and follow-up evaluations to monitor their recovery and outcomes over time. This study is currently looking for volunteers to help determine the best approach for ankle replacement surgery.

Gender

ALL

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