Validation of the Italian Forgotten Joint Score for ankle replacement patients
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
This study is testing a new Italian questionnaire to see if it accurately measures how well patients feel after having ankle replacement surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06091397 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the Italian version of the Forgotten Joint Score (FJS-12) specifically for patients who have undergone total ankle replacement surgery. It will assess the validity and reproducibility of this patient-reported outcome measure (PROM) through a translation-back-translation method. The study will involve a sample size of 120 patients, including those who have had surgery since 2018 and new patients on the waiting list. The goal is to improve the assessment of patient outcomes following ankle prosthetic replacement.
Who should consider this trial
Good fit: Ideal candidates are patients aged 25 to 80 who have undergone total ankle replacement surgery or are on the waiting list for the procedure.
Not a fit: Patients with a BMI over 40, those unable to consent, or those with psychological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the evaluation of patient outcomes and quality of life for individuals undergoing total ankle replacement.
How similar studies have performed: While this specific validation may be novel, similar studies validating PROMs for joint replacements have shown success in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bologna
- Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Antonio Mazzotti, MD PhD
- Email: antonio.mazzotti@ior.it
- Phone: 0516445064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.