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

Study Overview
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Brief Summary
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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.

Official Title
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Validation of the Italian Version of the Forgotten Joint Score (FJS-12) as a Patient-reported Outcome Measure in Total Ankle Replacement: a Study on an Italian Population

Conditions
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PROMs, Total Ankle Replacement, Italian Forgotten Joint Score

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IFJS - Italian Forgotten Join Score |  | At baseline (day 0) | 
| IFJS - Italian Forgotten Join Score |  | After 3 months | 
| IFJS - Italian Forgotten Join Score |  | After 6 months | 
| IFJS - Italian Forgotten Join Score |  | After 12 months | 
| IFJS - Italian Forgotten Join Score |  | After 24 months | 
| IFJS - Italian Forgotten Join Score |  | After 36 months | 
| IFJS - Italian Forgotten Join Score |  | After 48 months | 
| IFJS - Italian Forgotten Join Score |  | After 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Orthopedic Foot and Ankle Society (AOFAS score) |  | At baseline (day 0) | 
| American Orthopedic Foot and Ankle Society (AOFAS score) |  | After 3 months | 
| American Orthopedic Foot and Ankle Society (AOFAS score) |  | After 6 months | 
| American Orthopedic Foot and Ankle Society (AOFAS score) |  | After 12 months | 
| American Orthopedic Foot and Ankle Society (AOFAS score) |  | After 24 months | 
| American Orthopedic Foot and Ankle Society (AOFAS score) |  | After 36 months | 
| American Orthopedic Foot and Ankle Society (AOFAS score) |  | After 48 months | 
| American Orthopedic Foot and Ankle Society (AOFAS score) |  | After 60 months | 
| MOXFQ (Manchester-Oxford Foot Questionnaire) |  | At baseline (day 0) | 
| MOXFQ (Manchester-Oxford Foot Questionnaire) |  | After 3 months | 
| MOXFQ (Manchester-Oxford Foot Questionnaire) |  | After 6 months | 
| MOXFQ (Manchester-Oxford Foot Questionnaire) |  | After 12 months | 
| MOXFQ (Manchester-Oxford Foot Questionnaire) |  | After 24 months | 
| MOXFQ (Manchester-Oxford Foot Questionnaire) |  | After 36 months | 
| MOXFQ (Manchester-Oxford Foot Questionnaire) |  | After 48 months | 
| MOXFQ (Manchester-Oxford Foot Questionnaire) |  | After 60 months |