Clinical trial NCT06091397: Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: PROMs
Total Ankle Replacement
Italian Forgotten Joint Score
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: IFJS - Italian Forgotten Join Score
timeFrame: At baseline (day 0)
measure: IFJS - Italian Forgotten Join Score
timeFrame: After 3 months
measure: IFJS - Italian Forgotten Join Score
timeFrame: After 6 months
measure: IFJS - Italian Forgotten Join Score
timeFrame: After 12 months
measure: IFJS - Italian Forgotten Join Score
timeFrame: After 24 months
measure: IFJS - Italian Forgotten Join Score
timeFrame: After 36 months
measure: IFJS - Italian Forgotten Join Score
timeFrame: After 48 months
measure: IFJS - Italian Forgotten Join Score
timeFrame: After 60 months
Secondary outcomes:
measure: American Orthopedic Foot and Ankle Society (AOFAS score)
timeFrame: At baseline (day 0)
measure: American Orthopedic Foot and Ankle Society (AOFAS score)
timeFrame: After 3 months
measure: American Orthopedic Foot and Ankle Society (AOFAS score)
timeFrame: After 6 months
measure: American Orthopedic Foot and Ankle Society (AOFAS score)
timeFrame: After 12 months
measure: American Orthopedic Foot and Ankle Society (AOFAS score)
timeFrame: After 24 months
measure: American Orthopedic Foot and Ankle Society (AOFAS score)
timeFrame: After 36 months
measure: American Orthopedic Foot and Ankle Society (AOFAS score)
timeFrame: After 48 months
measure: American Orthopedic Foot and Ankle Society (AOFAS score)
timeFrame: After 60 months
measure: MOXFQ (Manchester-Oxford Foot Questionnaire)
timeFrame: At baseline (day 0)
measure: MOXFQ (Manchester-Oxford Foot Questionnaire)
timeFrame: After 3 months
measure: MOXFQ (Manchester-Oxford Foot Questionnaire)
timeFrame: After 6 months
measure: MOXFQ (Manchester-Oxford Foot Questionnaire)
timeFrame: After 12 months
measure: MOXFQ (Manchester-Oxford Foot Questionnaire)
timeFrame: After 24 months
measure: MOXFQ (Manchester-Oxford Foot Questionnaire)
timeFrame: After 36 months
measure: MOXFQ (Manchester-Oxford Foot Questionnaire)
timeFrame: After 48 months
measure: MOXFQ (Manchester-Oxford Foot Questionnaire)
timeFrame: After 60 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: 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.