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

NCT06311331 | Enrolling By Invitation FDA Device

• 1 other identifier: restor3d-007
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

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

Keywords

Avascular necrosis; Talus; Ankle joint

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who pass a composite of safety and probable benefit outcomes

  The primary endpoint for this post approval study is a composite of safety and probable benefit. The safety endpoint is defined by the absence of device-related SAE and subsequent secondary surgical intervention (SSSI) on the affected joints. The probable benefit endpoint is defined as joint salvage with the restor3d device still in place. This composite endpoint will be evaluated by determining the proportion of patients who do not have a device-related SAE or SSSI, AND have the restor3d implant in place at 5 years.

  At 5 years compared to baseline

Secondary Outcomes (10)

• Change in perceived pain from baseline

  At 5 years compared to baseline

• Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline

  At 5 years compared to baseline

• Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline

  At 5 years compared to baseline

• Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline

  At 5 years compared to baseline

• Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline

  At 5 years compared to baseline

Study Arms (1)

Total Talus Replacement

50 subjects receiving the Total Talus Replacement device

Device: Total Talus Replacement (TTR)

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.

Total Talus Replacement

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥22 years of age) who will receive a restor3d Total Talus Replacement device under an approved HDE for one of the indications listed on the Instructions for Use (IFU) and who do not have a contraindication (see Inclusion and Exclusion Criteria)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Restor3D: lead
• OrthoCarolina Research Institute, Inc.: collaborator

Study Sites (1)

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Osteonecrosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): November 1, 2031
• Study Completion (Estimated): November 1, 2031
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)