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
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