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Comparison of Customized and Standard Total Ankle Prostheses

RecruitingNAAges 40 Years - 75 YearsAllIstituto Ortopedico Rizzoli
NCT06193057 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement. * Consenting patients and able to complete scheduled study procedures and follow-up evaluations. * Patients who have signed the "informed consent" approved by the Ethics Committee. Exclusion Criteria: * Social conditions (homeless patients, with restrictions on personal freedom) * ASA 3 and 4 * Deep venous insufficiency Lower limbs * History of Erisipelas lower limbs * Neurological or psychocognitive disorders * neurological diseases * Axial deformities of ankle \>15° * Personal or family history of DVT or EP * Prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis) * Pregnant women * Patients with rheumatic diseases * Patients that requires ancillary surgical procedures
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What it tests

  • Total ankle arthroplasty
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Where

1 site
Rizzoli Orthopaedic Institute
Bologna, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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