Skip to main content
Avascular Necrosis of the TalusDevice

What this study is

This is a Humanitarian Device Exemption (HDE) approved device. The purpose of this study is to evaluate the continued safety and probable benefit of the restor3d Total Talus Replacement device in commercial use.

What's being tested

  • Total Talus Replacement (TTR)

    Intervention · DEVICE

    The restor3d patient-specific TTR Implant and Instrumentation System is designed to replace a native talus bone that has been affected by a disease state or injury. The implant is an additively manufactured Cobalt Chromium alloy (ASTM F3213) construct produced by laser powder bed fusion. The data-driven design of the implant enables the patient to salvage their joint while maintaining ankle range of motion, reducing pain and improving physical function.

Study details

Official title
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM): A Multicenter, Single Arm, Prospective, Post-approval Study for Patients Who Received the restor3d TTR Device to Evaluate Safety and Probable Benefit
Sponsor
Restor3D
Conditions
Avascular Necrosis of the Talus · Talar Osteochondral Defect of Ankle · Talar Dysfunction
Enrolling
50 people
Starts
2024-11-06
Est. completion
2031-11
Record
View on ClinicalTrials.gov ↗