Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Italian Forgotten Joint Score; PROMs; Total Ankle Replacement

Study type: Observational

Funder types: Other

Identifiers

NCT06091397

FORG-Score

Details and patient eligibility

About

The arthritic pathology of the tibio-tarsal joint has a prevalence of approximately 1% in the general population, and its incidence has been increasing over the years. Advanced-stage arthritis causes pain, impairs mobility, and has an extremely negative impact on patients' quality of life, resulting in significant social and economic costs. Unlike hip and knee arthritis, ankle arthritis is often secondary to traumatic events, affecting younger patients. An emerging treatment for severe ankle arthritis is ankle prosthetic replacement, and patient-reported outcome measures (PROMs) are increasingly used to assess patient outcomes. The study focuses on the validity and reproducibility of the Italian versione of the Forgotten Joint Score (FJS) in ankle prostheses, obtained through the translation-back-translation method, with a sample size of 120 patients.

Enrollment: 120 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of either gender, aged between 25 and 80 years;
• Patients who have undergone total ankle replacement surgery for tibio-tarsal joint pathology starting from 2018, as well as new patients on the waiting list.
• Signed informed consent for participation in the study;
• Patients who are prepared and motivated to attend the scheduled follow-up visits and complete the study questionnaires.

Exclusion criteria

• Patients unable to understand or consent;
• BMI > 40.
• Refusal to complete the study consent form.
• Substance abuse or psychological disorders that could interfere with the ability to comply with rehabilitation programs and postoperative assessments.
• Known sensitivity to device materials.
• Presence of an active or suspected latent infection in or around the affected ankle joint.