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Набор по приглашению NCT06311331

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

— Наблюдательное Avascular Necrosis of the Talus Talar Osteochondral Defect of Ankle Talar Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Total Talus Replacement (TTR).
Кому может быть актуально
Состояния в реестре: Avascular Necrosis of the Talus, Talar Osteochondral Defect of Ankle, Talar Dysfunction. Базовые параметры: от 22 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство 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.

Первичные конечные точки

  • Proportion of participants who pass a composite of safety and probable benefit outcomes [Срок оценки: At 5 years compared to baseline]
Вторичные конечные точки (10)
  • Change in perceived pain from baseline [Срок оценки: At 5 years compared to baseline]
  • Change in Foot and Ankle Outcome Score (FAOS) Composite score from baseline [Срок оценки: At 5 years compared to baseline]
  • Change in Foot and Ankle Outcome Score (FAOS) pain subscale score from baseline [Срок оценки: At 5 years compared to baseline]
  • Change in Foot and Ankle Outcome Score (FAOS) other symptoms subscale score from baseline [Срок оценки: At 5 years compared to baseline]
  • Change in Foot and Ankle Outcome Score (FAOS) activities of daily living (ADL) subscale score from baseline [Срок оценки: At 5 years compared to baseline]
  • Change in Foot and Ankle Outcome Score (FAOS) sports/recreation subscale score from baseline [Срок оценки: At 5 years compared to baseline]
  • Change in Foot and Ankle Outcome Score (FAOS) quality of life (QOL) subscale score from baseline [Срок оценки: At 5 years compared to baseline]
  • Change in ankle range of motion (ROM) from baseline [Срок оценки: At 5 years compared to baseline]
  • Proportion of procedure-related Serious Adverse Events [Срок оценки: At 5 years compared to baseline]
  • Proportion of Adverse Events [Срок оценки: At 5 years compared to baseline]

Критерии участия

Критерии включения

  • ≥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

Критерии исключения

  • 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.

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 · 1 центр
  • OrthoCarolina Research Institute, Inc. — Charlotte

Идентификаторы

NCT: NCT06311331 · restor3d-007

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗