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Prospective Evaluation of Clinical and Radiographic Outcomes Following Total Talus Replacement (PROCLAIM) | Clinical Trials | Clareo Health

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

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

NCT06311331•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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Locations (1)

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, United States

Key Dates

Start Date

November 6, 2024

Primary Completion Date

November 1, 2031

Completion Date

November 1, 2031

Last Updated

January 8, 2026

Enrollment

ESTIMATED participants

Conditions

Avascular Necrosis of the TalusTalar Osteochondral Defect of AnkleTalar Dysfunction

Interventions

Total Talus Replacement (TTR)

DEVICE

Talus Replacement Registry

NCT03965143

Avascular Necrosis of the Talus

View study

RECRUITINGNA

Clinical and Radiographic Outcomes After AMIC Treatment for Talus Osteochondral Lesion Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC

NCT03371121

Talar Osteochondral Defect of AnklePain+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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