Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-80
SponsorIstituto Ortopedico Rizzoli
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
At baseline (day 0)2
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
Time frame
After 3 months3
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
Time frame
After 6 months4
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
Time frame
After 12 monthsSecondary outcomes
1
American Orthopedic Foot and Ankle Society (AOFAS score)
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
Time frame
At baseline (day 0)2
American Orthopedic Foot and Ankle Society (AOFAS score)
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
Time frame
After 3 months3
American Orthopedic Foot and Ankle Society (AOFAS score)
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
Time frame
After 6 months4
American Orthopedic Foot and Ankle Society (AOFAS score)
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
Time frame
After 12 monthsSponsors and contacts
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Source ClinicalTrials.gov