About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Patients unable to understand or provide informed consent.
Pregnant women.
Body mass index (BMI) > 40.
Refusal to sign the informed consent form for study participation.
Trial design
Treatments tested in this trial
- Not listed