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Recruiting NCT06091397

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

— Observational PROMs Total Ankle Replacement Italian Forgotten Joint Score

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: PROMs, Total Ankle Replacement, Italian Forgotten Joint Score. Basic parameters: 25 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Primary outcome measures

  • IFJS - Italian Forgotten Join Score [Time frame: At baseline (day 0)]
  • IFJS - Italian Forgotten Join Score [Time frame: After 3 months]
  • IFJS - Italian Forgotten Join Score [Time frame: After 6 months]
  • IFJS - Italian Forgotten Join Score [Time frame: After 12 months]
  • IFJS - Italian Forgotten Join Score [Time frame: After 24 months]
  • IFJS - Italian Forgotten Join Score [Time frame: After 36 months]
  • IFJS - Italian Forgotten Join Score [Time frame: After 48 months]
  • IFJS - Italian Forgotten Join Score [Time frame: After 60 months]
Secondary outcome measures (12)
  • American Orthopedic Foot and Ankle Society (AOFAS score) [Time frame: At baseline (day 0)]
  • American Orthopedic Foot and Ankle Society (AOFAS score) [Time frame: After 3 months]
  • American Orthopedic Foot and Ankle Society (AOFAS score) [Time frame: After 6 months]
  • American Orthopedic Foot and Ankle Society (AOFAS score) [Time frame: After 12 months]
  • American Orthopedic Foot and Ankle Society (AOFAS score) [Time frame: After 24 months]
  • American Orthopedic Foot and Ankle Society (AOFAS score) [Time frame: After 36 months]
  • American Orthopedic Foot and Ankle Society (AOFAS score) [Time frame: After 48 months]
  • American Orthopedic Foot and Ankle Society (AOFAS score) [Time frame: After 60 months]
  • MOXFQ (Manchester-Oxford Foot Questionnaire) [Time frame: At baseline (day 0)]
  • MOXFQ (Manchester-Oxford Foot Questionnaire) [Time frame: After 3 months]
  • MOXFQ (Manchester-Oxford Foot Questionnaire) [Time frame: After 6 months]
  • MOXFQ (Manchester-Oxford Foot Questionnaire) [Time frame: After 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Istituto Ortopedico Rizzoli — Bologna

Publications

  • 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

Identifiers

NCT: NCT06091397 · FORG-Score

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗