Total Ankle Replacement: Clinical and Radiological Outcomes
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: Total ankle replacement.
- Who it may be relevant to
- Registry conditions: Ankle Arthritis. Basic parameters: from 18 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
Evaluation of Epidemiology and Radiological and Clinical Outcomes in Total Ankle Prosthesis
Overview
This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and radiographically.
Detailed description
The aim of this study is to evaluate radiographically and clinically using clinical and radiographic outcomes . Few studies exist in the literature and rarely report fix-bearing and mobile-bearing prosthetics \[1-4\]. Therefore the data related to this study can be considered a reference in the literature.
Patients who performed and will perform ankle prosthesis surgery from January 2011 to March 2026 and who underwent a clinical evaluation (also using questionnaires and scores) and radiographic evaluation.
The clinical data and radiological parameters were collected together with the visits and the procedures prescribed according to the clinical routine of the department.
Interventions
- Procedure Total ankle replacement
total ankle prosthesis through a lateral or an anterior approach
Primary outcome measures
- Changes in American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score [Time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively]
- Changes in Short form 12 (SF 12) [Time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively]
- Anterior distal tibial angle [Time frame: Pre operatively]
- Changes in beta angle [Time frame: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively]
- Changes in alpha angle [Time frame: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively]
- Medial distal tibial angle [Time frame: Pre operatively]
Secondary outcome measures (1)
- Changes in visual analogue scale [Time frame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively]
Eligibility criteria
Inclusion criteria
- Males and females
- age ≥ 18 years at the time of surgery
- patients who underwent ankle replacement surgery from January 2011 to March 2026
Exclusion criteria
\- age < 18 years at the time of surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- Irccs Istituto Ortopedico Galeazzi — Milan
Identifiers
NCT: NCT03650010 · Tarus