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.

Patients with degenerative pathology of the tibiotalar joint associated with significant bone loss or talar bone compromise, for whom further diagnostic evaluation using CT imaging is required to determine a potential surgical indication, will be included in this pilot study. In the case of confirmation of the indication for total ankle replacement with total talar substitution, patients will undergo a CT scan of the contralateral ankle for implant design (as per standard clinical practice for the development of patient-specific implants) and surgical planning. Following surgery, patients will be evaluated at subsequent follow-up visits according to routine clinical practice.

All study procedures will be conducted at Clinic I of the Rizzoli Orthopaedic Institute (patient selection and enrolment, and diagnostic imaging).

The study population consists of patients aged between 35 and 75 years affected by degenerative disease of the tibiotalar joint associated with severe bone loss or tala

**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.