clinical trial · NCT06311331
Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM)
Restor3D·—·enrolling by invitation·n = 50
Avascular Necrosis of the TalusTalar Osteochondral Defect of AnkleTalar DysfunctionTotal Talus Replacement (TTR)
brief 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.
started
Nov 6, 2024
primary completion
Nov 1, 2031
completion
Nov 1, 2031
last updated
Jan 8, 2026
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol