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Search / Trial NCT06091397

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

Launched by ISTITUTO ORTOPEDICO RIZZOLI · Oct 13, 2023

Trial Information

Current as of September 09, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the Italian version of a questionnaire called the Forgotten Joint Score (FJS-12) to see how well it works for patients who have had total ankle replacement surgery. The FJS-12 helps doctors understand how patients feel about their ankle function and quality of life after surgery. The trial aims to confirm that this version of the questionnaire is reliable and accurate for Italian-speaking patients who have undergone this type of surgery.

To participate in the trial, you need to be between 25 and 80 years old and have had total ankle replacement surgery since 2018, or be a new patient waiting for the surgery. You'll be asked to sign a consent form and attend follow-up visits to fill out questionnaires about your experience. It’s important to note that some individuals may not be eligible, such as those with severe obesity or certain medical conditions that could affect their recovery. If you decide to take part, your feedback will help improve treatment and support for future patients undergoing ankle replacement surgery.

Gender

ALL

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.

About Istituto Ortopedico Rizzoli

Istituto Ortopedico Rizzoli is a renowned orthopedic research and treatment institute based in Bologna, Italy, dedicated to advancing musculoskeletal health through innovative clinical trials and cutting-edge medical practices. With a strong emphasis on research, the institute collaborates with leading experts in orthopedics, rehabilitation, and related fields to develop and evaluate new therapies and surgical techniques. Committed to improving patient outcomes, Istituto Ortopedico Rizzoli not only focuses on high-quality clinical care but also fosters a robust research environment that supports the translation of scientific findings into clinical applications.

Locations

Bologna, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported