Validation study of the Forgotten Joint Score-12 as a universal patient-reported outcome measure.
Mikio Matsumoto, Tomonori Baba, Yasuhiro Homma...
https://pubmed.ncbi.nlm.nih.gov/26148699Actively Recruiting
Age: 25Years - 80Years
All Genders
ID06091397
Validation of the Italian Version of the Forgotten Joint Score (FJS-12) as a Patient-reported Outcome Measure in Total Ankle Replacement on an Italian Population
Led by Istituto Ortopedico Rizzoli · Updated on 2024-08-02
120
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of the Italian version of the Forgotten Joint Score (FJS-12) as a patient-reported outcome measure for individuals who have undergone total ankle replacement due to tibio-tarsal joint arthritis. This condition affects about 1% of the population and mainly impacts younger patients due to trauma, causing pain and limiting mobility. The study aims to validate the FJS-12's accuracy and reliability in this patient group by assessing 120 participants. The study includes patients who have had total ankle replacement surgery starting from 2018 or are on the waiting list for the procedure. Participants will be followed over five years, with assessments at baseline, 3, 6, 12, 24, 36, 48, and 60 months. These assessments will involve completing the Italian Forgotten Joint Score and other foot and ankle function questionnaires such as the American Orthopedic Foot and Ankle Society score and the Manchester-Oxford Foot Questionnaire. Participants will be asked to complete these questionnaires at scheduled follow-up visits to monitor joint function and quality of life after surgery. The study will collect patient-reported outcomes repeatedly over five years to evaluate the measurement tool's validity and reproducibility. This long-term follow-up will help to better understand patient experiences and outcomes after total ankle replacement surgery.
CONDITIONS
Brief Title
Validation of the Italian Version of the Forgotten Joint Score (FJS-12) in Total Ankle Replacement
Who Can Participate
Age: 25Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 or are new patients on the waiting list
- Signed informed consent for participation in the study
- Patients prepared and motivated to attend scheduled follow-up visits and complete study questionnaires
You will not qualify if you...
- Patients unable to understand or provide consent
- Body mass index (BMI) over 40
- Refusal to complete the study consent form
- Substance abuse or psychological disorders interfering with rehabilitation and postoperative assessments
- Known sensitivity to device materials
- Presence of active or suspected latent infection in or around the affected ankle joint
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 60 months
Participants who have undergone total ankle replacement surgery are observed and asked to complete questionnaires to evaluate their joint function and foot health over time.
Visits at baseline, 3, 6, 12, 24, 36, 48, and 60 months
Trial Site Locations
Total: 1 location
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
Loading map...
Research Team
A
Antonio Mazzotti, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here