Actively Recruiting

Age: 18Years - 90Years
All Genders
ID07168330

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants undergo total ankle replacement surgery as part of routine care.

1 visit (in-person)

Post-operative Follow-up

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

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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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