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.
On February 17th, 2021, the FDA officially approved the use of the first patient-specific 3D-printed talar implant for compassionate use. This is a patient-specific talar spacer designed to completely replace the talus for the treatment of talar avascular necrosis. The implant represents an alternative to other surgical procedures that allows joint preservation. Recently, at the First Clinic of the Rizzoli Orthopaedic Institute, a prosthetic device has been developed that combines the tibial and meniscal components of a FAR-type ankle prosthesis (Adler Ortho) with a total talus replacement implant. Since the device is patient-specific and implanted using custom-made cutting guides, it reduces surgical invasiveness on surrounding bone structures as well as on ligamentous and tendinous structures, thereby preserving ankle function as much as possible. The customization is based on a next-generation prosthetic model produced using additive manufacturing technology and featuring hypoallergenic properties, as it is made of a titanium alloy and treated with a nitriding process. The aim of this study is therefore to evaluate the outcomes of this prosthetic device over time.
• Male or female patients aged between 35 and 75 years.
• Pathology of the tibiotalar joint requiring surgical intervention with prosthetic replacement.
• Severe cases of bone loss or talar bone compromise.
• Customisation performed at the Rizzoli Orthopaedic Institute.
• Signed informed consent for participation in the study.
• Patients must be prepared and motivated to comply with preoperative and postoperative investigations, rehabilitation protocols, follow-up schedules, and study questionnaires.