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

NCT06311331 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-01-08

No results posted yet for this study

Summary

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.

Conditions

  • Avascular Necrosis of the Talus
  • Talar Osteochondral Defect of Ankle
  • Talar 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.

Sponsors & Collaborators

  • OrthoCarolina Research Institute, Inc.

    collaborator OTHER

  • Restor3D

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-06
Primary Completion
2031-11-30
Completion
2031-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06311331 on ClinicalTrials.gov