Actively Recruiting
Comparison of Customized and Standard Total Ankle Prostheses
Led by Istituto Ortopedico Rizzoli · Updated on 2025-12-29
24
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this study is to compare primary total ankle replacement (TAR) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TARs, considering: objective radiological results, subjective patient outcomes, and overall costs of both procedures
CONDITIONS
Official Title
Comparison of Customized and Standard Total Ankle Prostheses
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 40 to 75 years with arthritis in one ankle joint who are candidates for primary total ankle replacement
- Able and willing to complete all scheduled study procedures and follow-up visits
- Signed informed consent form approved by the Ethics Committee
You will not qualify if you...
- Homeless or socially restricted individuals
- Patients with ASA classification 3 or 4
- Deep venous insufficiency in lower limbs
- History of erysipelas in lower limbs
- Neurological or cognitive disorders
- Neurological diseases
- Ankle deformities greater than 15 degrees
- Personal or family history of deep vein thrombosis or pulmonary embolism
- Previous prosthetic or joint fusion surgeries in other lower extremity joints (except for the ankle being treated)
- Pregnant women
- Patients with rheumatic diseases
- Patients requiring additional surgical procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rizzoli Orthopaedic Institute
Bologna, BO, Italy, 40126
Actively Recruiting
Research Team
M
massimiliano mosca, MD
CONTACT
S
silvio caravelli, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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