Actively Recruiting

Age: 25Years - 80Years
All Genders
NCT06091397

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

Led by Istituto Ortopedico Rizzoli · Updated on 2024-08-02

120

Participants Needed

1

Research Sites

287 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 25Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Patients unable to understand or consent
  • Body mass index (BMI) greater than 40
  • Refusal to complete the study consent form
  • Substance abuse or psychological disorders that could interfere with compliance with rehabilitation and postoperative assessments
  • Known sensitivity to device materials
  • Presence of an active or suspected latent infection in or around the affected ankle joint

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Actively Recruiting

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Research Team

A

Antonio Mazzotti, MD PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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