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Study identifier: NCT07569848 Synced from ClinicalTrials.gov · July 28, 2026
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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.

Condition: Arthrosis · Ankle Arthritis · Ankle Replacement  ·  Sponsor: Istituto Ortopedico Rizzoli

PhaseN/A
Planned participants26
Who can joinAll sexes, 35 Years to 75 Years
Healthy volunteersNo

About this 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.

This description comes directly from the study's public registry record.

Talk to the study team

Antonio Mazzotti, PhD MD  ·  +39 349 879 8863  ·  antonio.mazzotti@ior.it

Always discuss trial participation with your own doctor first.

Locations (1)

Istituto Ortopedico RizzoliBologna, ItalyRecruiting

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Source record: clinicaltrials.gov/study/NCT07569848