Custom 3D-printed total ankle and talus replacement for severe bone loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center pilot observational effort uses patient-specific, additive-manufactured talar implants combined with tibial and meniscal components of a FAR-type ankle prosthesis and custom cutting guides to minimize bone and soft-tissue disruption. Devices are customized at the Istituto Ortopedico Rizzoli and implanted in patients whose tibiotalar pathology requires prosthetic replacement and who meet inclusion criteria. The approach aims to preserve joint mechanics and reduce the need for more invasive salvage procedures by restoring anatomy with a bespoke implant. Participants will undergo standardized preoperative planning, surgery at the Rizzoli center, and postoperative rehabilitation and follow-up per the study protocol.

Why it matters

Who can join: the full rules

\*\*INCLUSION CRITERIA:\*\*

1. Male or female patients aged between 35 and 75 years.
2. Pathology of the tibiotalar joint requiring surgical intervention with prosthetic replacement.
3. Severe cases of bone loss or talar bone compromise.
4. Customisation performed at the Rizzoli Orthopaedic Institute.
5. Signed informed consent for participation in the study.
6. Patients must be prepared and motivated to comply with preoperative and postoperative investigations, rehabilitation protocols, follow-up schedules, and study questionnaires.

\*\*EXCLUSION CRITERIA:\*\*

1. Patients unable to understand or provide informed consent.
2. Pregnant women.
3. Body mass index (BMI) \> 40.
4. Refusal to sign the informed consent form for study participation.
5. Substance abuse or psychological disorders that may interfere with adherence to rehabilitation and postoperative assessment protocols.
6. Known hypersensitivity to device materials.
7. Active or suspected latent infection in or around the affected ankle joint.
8. Previous orthopaedic surgery on the lower limbs within the last year, or planned orthopaedic surgery within one year (excluding ankle replacement).
9. Presence of neuromuscular or neurosensory deficits limiting the ability to assess device safety and efficacy.
10. Diagnosis of systemic disease (e.g., systemic lupus erythematosus) or metabolic disorder (e.g., Paget's disease of bone) leading to progressive bone deterioration.
11. Immunosuppression or excessive steroid therapy beyond physiological requirements (e.g., \>30 days).
12. Pregnant and/or fertile women.

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Study coordinator: Antonio Mazzotti, PhD MD
• Email: antonio.mazzotti@ior.it
• Phone: +39 349 879 8863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.