Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
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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