NCT06193057 Comparison of Customized and Standard Total Ankle Prostheses
| NCT ID | NCT06193057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Ankle Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-07-26 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2023-07-26 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06193057 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Ankle Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06193057 currently recruiting?
Yes, NCT06193057 is actively recruiting participants. Contact the research team at massimiliano.mosca@ior.it for enrollment information.
Where is the NCT06193057 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06193057 clinical trial?
NCT06193057 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 24 participants.