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

Recruiting

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

• Registration Number: NCT06091397
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Primary Completion: 2027-12
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IFJS - Italian Forgotten Join Score	After 60 months	The Italian Forgotten Joint Score (FJS) is the italian versione of the Forgotten Joint score that is a 12-question patient-reported outcomes measure created to measure a patient's awareness of their artificial joint. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. 0 worst possible score, 100 best possible score

Secondary Outcome Measures

Name	Time	Method
American Orthopedic Foot and Ankle Society (AOFAS score)	After 60 months	The American Orthopedic Foot and Ankle Society Score is a semi-objective rating scale that evaluates ankle pain, motion and alignment and ranges from 0 to 100 points. 0 worst possible score, 100 best possible score
MOXFQ (Manchester-Oxford Foot Questionnaire)	After 60 months	The MOXFQ is a 16-item instrument answered on a five-point Likert scale (each item is scored from 0 to 4, with 4 denoting 'most severe'). Scores for each item are summed to form three separate subscales representing underlying domains: walking/standing problems (seven items), foot pain (five items), and issues related to social interaction (four items). Raw scale scores are then each converted to a metric from 0 to 100, where 100 denotes the most severe.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy