Patient Specific Talus Spacer Post Approval Study

Study Overview
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Brief Summary
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Humanitarian Device Exemption Approved Patient Specific Talus Spacer Post Approval Study.

Detailed Description
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This is a Humanitarian Device Exemption (HDE) approved device called the Patient Specific Talus Spacer. This is a post approval study to determine the safety and probable benefit of the Patient Specific Talus Spacer in commercial use. The Patient Specific Talus Spacer is a solid polished replica of the patient's bone to allow the patient to regain motion and reduce pain.

Official Title
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Patient Specific Talus Spacer Post Approval Study

Conditions
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Avascular Necrosis of the Talus

Intervention / Treatment
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* Device: Patient Specific Talus Spacer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject plans to undergo implantation of the Patient Specific Talus Spacer for avascular necrosis of the ankle joint independent of this research protocol; Avascular necrosis of the ankle joint; Age 21 years old or older; Subject has good general health; and Subject signs a written informed consent form (ICF) prior to the surgical procedure. Exclusion Criteria: Presence of any contraindication identified in the device Instructions for Use; Surgeon determines that the patient is not appropriate for the Talus Spacer procedure based on the device IFU (including the enumerated Warnings and Precautions); Based on the medical opinion of the surgeon, the patient is not appropriate for the Talus Spacer procedure; For female subjects, pregnancy; Active systemic disease, such as AIDS, HIV, or active infection; Active infection or the skin is compromised at the surgical site; and Systemic disease that would affect the subject's welfare; Is a prisoner, incarcerated, or has been coerced to participate in the study that could impact the validity of results; Is currently participating in an investigational therapy (device and/or pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the time course of follow-up. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Cobalt Chromium Patient Specific Talus Spacer, and the surgeon believes that a Cobalt Chromium Patient Specific Talus Spacer is the best option for the patient. If the Sponsor has notified the site that 30 subjects have been enrolled in the study with a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer, and the surgeon believes that a Titanium (Ti6Al4V) with Titanium Nitride (TiN) coating Patient Specific Talus Spacer is the best option for the patient.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 50 Subjects<br>50 Subjects Receiving the Patient Specific Talus Spacer. | Device: Patient Specific Talus Spacer<br>* Patient Specific Talus Spacer is a solid polished replica of the patient's bone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) | Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) at 5 years compared to baseline on the 0 to 100mm scale. A lower score will indicate an improvement in pain. | At 5 years compared to Baseline | 
| A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits | A lack Secondary Subsequent Surgical Intervention (SSSI) at 5 years Post Operative | A patient will achieve the primary probable benefit endpoint only is they do not undergo a Secondary Subsequent Surgical Intervention at 5 years Post Operative as assessed during the subjects visits for the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle. | Additional analyses will be performed to observe improvement at 5-years post-procedure compared to baseline on ankle range of motion (ROM) as assessed by the surgeon at each follow up visit through 5 years Post Operative. | 5 Years Post Procedure compared to baseline. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Avascular Necrosis, Talus, Ankle