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.

\*\*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.