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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 80
View:

• 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.

Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Contact Information
Primary
Antonio Mazzotti, MD PhD
antonio.mazzotti@ior.it
0516445064
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2028-01
Participants
Target number of participants: 120
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli

This content was sourced from clinicaltrials.gov