Patient Specific Talus Spacer Post Approval Study

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство Patient Specific Talus Spacer
  Patient Specific Talus Spacer is a solid polished replica of the patient's bone.

Первичные конечные точки

• Clinically Significant Improvement in Pain on the Visual Analog Scale (VAS) [Срок оценки: At 5 years compared to Baseline]
• A lack Secondary Subsequent Surgical Intervention at 5 years Post Operative assessed during the subject's visits [Срок оценки: 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.]

Вторичные конечные точки (1)

• Additional Analyses at 5 years Post Operative compared to baseline, Range of Motion of the Ankle. [Срок оценки: 5 Years Post Procedure compared to baseline.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 6 центров

• Redwood Orthopaedics — Santa Rosa
• Fort Wayne Orthopedics — Fort Wayne
• Mercy Institute for Foot & Ankle Reconstruction — Baltimore
• Duke Orthopeadics Arringdon — Morrisville
• Medical University of South Carolina — Charleston
• UT Physicians Orthopedics - Pearland — Pearland

Идентификаторы

NCT: NCT05364606 · AOPSTSPAS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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