Actively Recruiting
Evaluation of Epidemiology and Radiological and Clinical Outcomes in Total Ankle Prosthesis
Led by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Updated on 2018-08-28
1066
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the epidemiology and outcomes of ankle joint surgery in patients who underwent total ankle replacement between January 2011 and March 2026. The study aims to assess both clinical and radiographic results, focusing on the use of fix-bearing and mobile-bearing prosthetics, which are not widely reported in existing literature. This research seeks to provide important reference data on the effectiveness of ankle prostheses. Participants include patients who had total ankle prosthesis surgery performed via either a lateral or anterior approach. The study collects clinical data and radiological parameters through routine clinical visits, including the use of questionnaires and scoring systems. The evaluation covers a broad time span, from the pre-operative period through various post-operative milestones up to 120 months. During the study, participants' ankle function and pain levels are measured using tools like the American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score and the Short Form 12 (SF-12) health survey at multiple intervals before and after surgery. Radiographic angles such as the anterior distal tibial angle and medial distal tibial angle are also assessed. The study includes long-term follow-up to monitor changes and outcomes of total ankle replacement over time.
CONDITIONS
Brief Title
Total Ankle Replacement: Clinical and Radiological Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females
- Age 18 years or older at the time of surgery
- Patients who underwent ankle replacement surgery between January 2011 and March 2026
You will not qualify if you...
- Age younger than 18 years at the time of surgery
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo total ankle replacement surgery through a lateral or an anterior approach, followed by immediate post-operative care.
1 surgery visit and immediate post-operative care
Duration - Up to 120 months post-operatively
Participants are monitored with clinical evaluations and radiographic assessments at multiple time points to track recovery and outcomes after surgery.
Visits at 2, 6, and 12 months post-operatively, then annually up to 10 years
Trial Site Locations
Total: 1 location
1
Irccs Istituto Ortopedico Galeazzi
Milan, Milano, Italy, 20156
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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