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.

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.