Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT06311331

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

Sponsor: Restor3D

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.

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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2024-11-06

Completion Date

2031-11

Last Updated

2026-01-08

Healthy Volunteers

No

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.

Locations (1)

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, United States