Comparing customized and standard ankle replacements
Official title: Comparison of Customized and Standard Total Ankle Prostheses: a Pilot Study
Run by Istituto Ortopedico Rizzoli · NCT06193057 · Data updated 2026-11-12
This study is testing whether customized ankle replacements made just for you work better than standard ones for people with ankle osteoarthritis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 75 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Locations | 1 site (Bologna, BO) |
| Status | Recruiting |
| Started | July 26, 2023 |
| Main results expected | April 30, 2026 |
| Study ends | April 26, 2027 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT06193057 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 40 to 75 with unilateral ankle osteoarthritis who are suitable for primary total ankle replacement.
✕Probably not a fit
Patients with severe comorbidities, neurological disorders, or those requiring additional surgical procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the outcomes of customized total ankle replacements (TAR) tailored to individual patients' ankle morphology with standard TAR procedures. It will evaluate objective radiological results, subjective patient outcomes, and the overall costs associated with both approaches. The customized prostheses are designed using tomographic scans and implanted with patient-specific cutting guides. The goal is to determine which method provides better results for patients suffering from ankle osteoarthritis.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and patient satisfaction for those undergoing ankle replacement surgery.
How similar studies have gone: Other studies have shown promising results with customized orthopedic implants, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Rizzoli Orthopaedic Institute
Bologna, Bo, Italy Recruiting
Study contacts
- Study coordinator: massimiliano mosca, MD
- Email: massimiliano.mosca@ior.it
- Phone: 0516366
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.