Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ankle replacement.
- Who it may be relevant to
- Registry conditions: Orthopedic Disorder. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical and Radiological Evaluation in Patients With Total Ankle Replacement
Overview
Numerous studies reported the efficacy of new third-generation of total ankle arthroplasties for the treatment of advanced ankle osteoarthritis and clinical results are comparable to ankle arthrodesis. The improvement in knowledge of ankle joint biomechanics, instrumentation, surgical approach may led to even higher clinical results in comparison to arthrodesis. Many of the studies reporting the results of ankle replacement are provided by surgeons involved at least in the initial design of the implant. Thus, familiarity with the system can be a potential bias affecting outcomes and orthopedic surgeons may find difficulties in reproducing the results. In this study, we will assess the clinical and radiological outcomes in patients who underwent this procedure performed by non-designer surgeons
Detailed description
Patients who underwent total ankle replacement will be unrolled in this study. Clinical assessment is collected pre- and post-operatively with minimum follow-up of 12 months from each patients using the American Orthopedic Foot and Ankle (AOFAS) score, the Foot Function Index and the visual analogue scale (VAS) for pain.
Weightbearing anteriorposterior and lateral radiographs of the ankle are collected pre-operatively and at the last follow-up for all of the patients and independently evaluated by an orthopedic surgeon.
Interventions
- Device Ankle replacement
Total ankle arthroplasty
Primary outcome measures
- survivorship [Time frame: 10 years]
Secondary outcome measures (6)
- angle a [Time frame: 10 years]
- angle b [Time frame: 10 years]
- angle y [Time frame: 10 years]
- offset ratio [Time frame: 10 years]
- AOFAS score [Time frame: 10 years]
- Foot function Index [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- patients treated with ankle replacement for osteoarthritis
- The patient is willing and able to complete scheduled follow-up evaluations questionnaires and radiographic examination as described in the Informed Consent
Exclusion criteria
- patients without radiographic follow-up
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Galeazzi — Milan
Identifiers
NCT: NCT07168330 · ProtesiTT