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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Avascular Necrosis of the Talus; Talar Osteochondral Defect of Ankle; Talar Dysfunction
• Intervention / Treatment: Device: Total Talus Replacement (TTR)

• Study Type: Observational
• Enrollment (Estimated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Total Talus Replacement; 50 subjects receiving the Total Talus Replacement device

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived pain from baseline	Scores on the 11-point Pain Numeric Rating Scale (NRS) rated from 0-10 where higher scores indicate worse pain	At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline	Foot and Ankle Outcome Score (FAOS) is a 42-item questionnaire with 5 subscales: pain (9 items), other symptoms (7 items), activities of daily living (ADL) (17 items), sports/recreation (5 items), and quality of life (4 items). Each question is graded from 0 to 4 on a 5-point Likert scale (none, mild, moderate, severe, and extreme problems). Composite FAOS scores include all 42-items across the 5 subscales, scored together to provide one comprehensive value. The FAOS composite score ranges from 0 to 100 where a score of 0 indicates the worst possible symptoms, and a score of 100 indicates no symptoms.	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
Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline		At 5 years compared to baseline
Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline		At 5 years compared to baseline
Change in ankle range of motion (ROM) from baseline	Ankle ROM will be evaluated using a goniometer to determine the change in degrees of plantarflexion and dorsiflexion	At 5 years compared to baseline
Proportion of procedure-related Serious Adverse Events	Procedure-related Serious Adverse Event will be defined as the number of patients who have a procedure-related event including: death, life-threatening condition, hospital admission (initial or prolonged), disability or permanent damage, or required intervention to prevent permanent impairment or damage.	At 5 years compared to baseline
Proportion of Adverse Events	Adverse Event will be defined as the number of patients who have a non-serious, unexpected procedure- or device-related event before 5 years post-implantation.	At 5 years compared to baseline

Collaborators and Investigators

• Sponsor: Restor3D

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Avascular necrosis; Talus; Ankle joint
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis
• Other Study ID Numbers: restor3d-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No