Clinical Trial

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

Enrolling by Invitation
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-03-13; most recent amendment 2026-01-06.
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-11-12
Trial Details
NCT Number NCT06311331
Lead Sponsor Restor3D
Collaborators: OrthoCarolina Research Institute, Inc.
Conditions Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle, Talar Dysfunction
Enrollment 50 participants
Start Date 2024-11-06
Primary Completion 2031-11 (estimated)
Study Completion 2031-11 (estimated)
Updated on ClinicalTrials.gov 2026-01-08