Status:
RECRUITING
Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
PROMs
Total Ankle Replacement
Eligibility:
All Genders
25-80 years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06091397
Start Date
July 1 2022
End Date
January 1 2028
Last Update
August 2 2024
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136