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

NCT06091397 | Recruiting

• 1 other identifier: FORG-Score
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

PROMs; Total Ankle Replacement; Italian Forgotten Joint Score

Outcome Measures

Primary Outcomes (8)

• IFJS - Italian Forgotten Join Score

  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

  At baseline (day 0)

• IFJS - Italian Forgotten Join Score

  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

  After 3 months

• IFJS - Italian Forgotten Join Score

  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

  After 6 months

• IFJS - Italian Forgotten Join Score

  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

  After 12 months

• IFJS - Italian Forgotten Join Score

  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

  After 24 months

• IFJS - Italian Forgotten Join Score

  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

  After 36 months

• IFJS - Italian Forgotten Join Score

  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

  After 48 months

• IFJS - Italian Forgotten Join Score

  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

  After 60 months

Secondary Outcomes (16)

• 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

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients aged between 25 and 80 years, suffering from degenerative pathology of the tibio-tarsal joint, who have undergone surgical total ankle prosthetic replacement.

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related 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/s00590-015-1660-z. Epub 2015 Jul 7.

  PMID: 26148699 RESULT

Central Study Contacts

Antonio Mazzotti, MD PhD

CONTACT

0516445064; antonio.mazzotti@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: July 1, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)