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

Outcomes of Surgical Treatment Using a Custom-made Device for Total Ankle and Talar Replacement in the Management of Severe Cases of Bone Loss or Bone Compromise: a Pilot Study.

This project will try a custom 3D-printed ankle and talus implant to restore function in adults aged 35–75 with severe talar bone loss or compromised ankle bone.

Quick facts

• Study type: Observational
• Enrollment: 26 (estimated)
• Ages: 35 Years to 75 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (Academic / other)
• Locations: 1 site (Bologna)
• Trial ID: NCT07569848 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 35 to 75 with tibiotalar pathology requiring prosthetic replacement and severe talar bone loss who can provide informed consent and commit to the required rehabilitation and follow-up are ideal candidates.

Not a fit: Patients who are pregnant, have BMI > 40, active or suspected infection, known hypersensitivity to device materials, substance abuse or severe psychiatric issues, or who cannot adhere to rehabilitation and follow-up are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could preserve ankle joint function, reduce pain, and offer an alternative to fusion or more destructive surgeries in patients with severe talar compromise.

How similar studies have performed: A patient-specific 3D-printed talar implant received FDA compassionate-use recognition in 2021 and early case reports show promise, but large-scale, long-term evidence for combined total ankle and talus replacements remains limited.

Eligibility criteria

\*\*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 this trial is running

Bologna

• Istituto Ortopedico Rizzoli — Bologna, Italy (Recruiting)

Study contacts

• Study coordinator: Antonio Mazzotti, PhD MD

Conditions Arthrosis; Ankle Arthritis; Ankle Replacement