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

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Restor3D
Study ID
NCT06311331
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total Talus Replacement (TTR) — 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.

Study Details

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.

Key Dates

Start date
Nov 6, 2024
Status verified
Jan 2026
Primary completion
Nov 30, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Total Talus Replacement
    50 subjects receiving the Total Talus Replacement device

Primary Outcome Measure

Proportion of participants who pass a composite of safety and probable benefit outcomes [ Time Frame: At 5 years compared to baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
OrthoCarolina Research Institute, Inc.CharlotteNorth Carolina28207-

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OrthoCarolina Research Institute, Inc.· Charlotte, NC

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