Validation of the Italian Forgotten Joint Score for ankle replacement patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: Antonio Mazzotti, MD PhD
• Email: antonio.mazzotti@ior.it
• Phone: 0516445064

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Affordable, tailored physical therapy for financially vulnerable people after trauma

  We’re testing whether a patient-friendly, low-cost approach to physical therapy helps adults with trauma injuries who are financially vulnerable maintain or improve their quality of life.

  Recruiting Radboud University Medical Center · Nijmegen, Gelderland · NCT07795216

• A child-friendly way for kids to report their experiences around anesthesia and surgery

  This project will test a Danish translation of a child-friendly recovery and experience questionnaire (PedSQoR) with 4–12-year-old surgical patients to let children report their own perioperative outcomes and experiences.

  Recruiting at 3 sites Gødstrup Hospital · Aarhus, Central Jutland and 2 other locations · NCT07289152

• Follow-up of the Incompass Total Ankle System after total ankle replacement surgery.

  The Incompass Total Ankle System will be followed to see if it is safe and helps reduce pain and improve quality of life in adults having total ankle replacement.

  Recruiting at 5 sites Stryker Trauma and Extremities · Morton Grove, Illinois and 4 other locations · NCT07118501

• Using patient-reported questionnaires to monitor quality of life during first-line chemo-immunotherapy for advanced NSCLC

  This project will test whether regular online questionnaires about symptoms and quality of life can help track health and treatment effects in adults with stage IV NSCLC starting first-line chemo-immunotherapy.

  Recruiting IRCCS San Raffaele · Milan, Italy · NCT07061379

• Using patient-reported outcomes and experiences in routine healthcare

  This study is testing if using a smartphone app to collect feedback from patients about their health and experiences can improve care and satisfaction for adults with conditions like cancer or those having weight loss surgery.

  Recruiting Parc de Salut Mar · Barcelona, Catalonia · NCT06272552

• Evaluating the ERAS program's impact on recovery after pancreatic surgery

  This study is testing if following a special recovery program can help people recover better after pancreatic surgery.

  Recruiting University of Thessaly · Larissa · NCT05518643

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.