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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- IFJS - Italian Forgotten Join Score
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients unable to understand or consent;
- •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.
结局指标
主要结局
IFJS - Italian Forgotten Join Score
时间窗: After 60 months
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
次要结局
- American Orthopedic Foot and Ankle Society (AOFAS score)(After 60 months)
- MOXFQ (Manchester-Oxford Foot Questionnaire)(After 60 months)
研究者
Antonio Mazzotti
Principal Investigator
Istituto Ortopedico Rizzoli