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

NCT ID: NCT06311331

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-06
• Study Completion Date: 2031-11-30

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.

Conditions

Avascular Necrosis of the Talus; Talar Osteochondral Defect of Ankle; Talar Dysfunction

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Total Talus Replacement

50 subjects receiving the Total Talus Replacement device

Total Talus Replacement (TTR)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• ≥22 Years of Age
• Scheduled to receive TTR implant for one of the following indications:
• Avascular necrosis of the talus
• Avascular necrosis of the talus in addition to talar collapse, cysts or non-union
• Large, uncontained, unstable, or cystic talar osteochondral defects with risk of collapse or talar osteochondral defects not responsive to traditional treatments
• Nonunion following talar fracture or talar extrusion, unresponsive to more conservative treatments
• Have not had a prior Total Talus Replacement device implanted
• Not planning to receive bilateral Total Talus Replacement devices
• Subject signs a written informed consent form (ICF) prior to the surgical procedure

Exclusion Criteria

• Surgical procedures other than those listed in the indications for use.
• Use of implant greater than 6 months from date of patient's preoperative CT scan.
• Degenerative changes in the tibiotalar, subtalar or talonavicular joints.
• Gross deformity in sagittal or coronal planes. More than 15 degrees of varus or valgus deformity in the coronal plane, or more than 50% subluxation anteriorly or posteriorly of the talus in the sagittal plane
• Patients with an active local or systemic infection.
• Osteonecrosis of the calcaneus, distal tibia or navicular.
• Known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site.
• Blood supply limitations and previous infections that may prevent healing.
• Physical conditions that would eliminate adequate implant support or prevent healing, including inadequate soft tissue coverage.
• Conditions which may limit the patient's ability or willingness to restrict activities or follow directions postoperatively during the healing period.
• Presence of neurological deficit which would prevent patient postoperative compliance.
• Patients with foreign body sensitivity, suspected or documented material allergy or intolerance. Where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role: collaborator

Restor3D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, United States

Countries

United States

Other Identifiers

restor3d-007

Identifier Type: -

Identifier Source: org_study_id