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

PROMs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091397
• Other study ID #: FORG-Score
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: January 2028

Study information

• Verified date: October 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Antonio Mazzotti, MD PhD
• Phone: 0516445064
• Email: antonio.mazzotti[@]ior.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 2028
• Est. primary completion date: December 2027
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• PROMs

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Matsumoto M, Baba T, Homma Y, Kobayashi H, Ochi H, Yuasa T, Behrend H, Kaneko K. Validation study of the Forgotten Joint Score-12 as a universal patient-reported outcome measure. Eur J Orthop Surg Traumatol. 2015 Oct;25(7):1141-5. doi: 10.1007/s00590-015- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IFJS - Italian Forgotten Join Score		At baseline (day 0)
Primary	IFJS - Italian Forgotten Join Score		After 3 months
Primary	IFJS - Italian Forgotten Join Score		After 6 months
Primary	IFJS - Italian Forgotten Join Score		After 12 months
Primary	IFJS - Italian Forgotten Join Score		After 24 months
Primary	IFJS - Italian Forgotten Join Score		After 36 months
Primary	IFJS - Italian Forgotten Join Score		After 48 months
Primary	IFJS - Italian Forgotten Join Score		After 60 months
Secondary	American Orthopedic Foot and Ankle Society (AOFAS score)		At baseline (day 0)
Secondary	American Orthopedic Foot and Ankle Society (AOFAS score)		After 3 months
Secondary	American Orthopedic Foot and Ankle Society (AOFAS score)		After 6 months
Secondary	American Orthopedic Foot and Ankle Society (AOFAS score)		After 12 months
Secondary	American Orthopedic Foot and Ankle Society (AOFAS score)		After 24 months
Secondary	American Orthopedic Foot and Ankle Society (AOFAS score)		After 36 months
Secondary	American Orthopedic Foot and Ankle Society (AOFAS score)		After 48 months
Secondary	American Orthopedic Foot and Ankle Society (AOFAS score)		After 60 months
Secondary	MOXFQ (Manchester-Oxford Foot Questionnaire)		At baseline (day 0)
Secondary	MOXFQ (Manchester-Oxford Foot Questionnaire)		After 3 months
Secondary	MOXFQ (Manchester-Oxford Foot Questionnaire)		After 6 months
Secondary	MOXFQ (Manchester-Oxford Foot Questionnaire)		After 12 months
Secondary	MOXFQ (Manchester-Oxford Foot Questionnaire)		After 24 months
Secondary	MOXFQ (Manchester-Oxford Foot Questionnaire)		After 36 months
Secondary	MOXFQ (Manchester-Oxford Foot Questionnaire)		After 48 months
Secondary	MOXFQ (Manchester-Oxford Foot Questionnaire)		After 60 months