Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)

Enrolling by invitationOBSERVATIONAL
Enrollment

50

Participants

Timeline

Start Date

November 6, 2024

Primary Completion Date

November 30, 2031

Study Completion Date

November 30, 2031

Conditions
Avascular Necrosis of the TalusTalar Osteochondral Defect of AnkleTalar Dysfunction
Interventions
DEVICE

Total Talus Replacement (TTR)

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.

Trial Locations (1)

28207

OrthoCarolina Research Institute, Inc., Charlotte

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

OrthoCarolina Research Institute, Inc.

OTHER

lead

Restor3D

INDUSTRY