Actively Recruiting
Clinical and Radiological Evaluation in Patients With Total Ankle Replacement
Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2025-09-17
100
Participants Needed
1
Research Sites
530 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the clinical and radiological outcomes in patients who have undergone total ankle replacement for advanced ankle osteoarthritis. The study aims to assess results achieved by surgeons who did not originally design the implant, addressing potential bias seen in prior studies where designers performed the surgeries. The goal is to compare these outcomes with those of ankle arthrodesis, considering improvements in surgical techniques and ankle biomechanics knowledge. Participants in the study have received total ankle arthroplasty using a third-generation ankle replacement device. Clinical assessments are performed before and after surgery, with a minimum follow-up of 12 months. These include the American Orthopedic Foot and Ankle (AOFAS) score, the Foot Function Index, and the visual analogue scale (VAS) for pain. Weightbearing ankle X-rays are taken before surgery and at the final follow-up, with independent review by an orthopedic surgeon. During the study, participants complete scheduled follow-up evaluations, questionnaires, and radiographic exams. Researchers measure implant survivorship over 10 years along with various ankle joint angles and functional scores. The study monitors clinical progress, radiological changes, and foot function to evaluate long-term outcomes of the ankle replacement procedure.
CONDITIONS
Brief Title
Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients treated with ankle replacement for osteoarthritis
- Patient is willing and able to complete scheduled follow-up evaluations, questionnaires, and radiographic examinations as described in the Informed Consent
You will not qualify if you...
- Patients without radiographic follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo total ankle replacement surgery as part of routine care.
1 visit (in-person)
Duration - At least 12 months
Participants have clinical assessments and radiographs collected before and after surgery, with a minimum follow-up of 12 months to evaluate function and implant survivorship.
Multiple visits over 12 months including pre-operative and last follow-up assessments
Trial Site Locations
Total: 1 location
1
IRCCS Galeazzi
Milan, Italy
Actively Recruiting
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
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