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Набор скоро начнётся NCT07563803

The restor3d Outcomes Registry

— Наблюдательное Joint Replacement Arthropathy

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: Patient-Specific Orthopedic Implant.
Кому может быть актуально
Состояния в реестре: Joint Replacement, Arthropathy. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
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

The restor3d Outcomes Registry: Tracking Patient Recovery After Joint Replacement

Обзор

The restor3d Outcomes Registry is a prospective, longitudinal, decentralized study designed to capture patient-reported outcomes (PROs) from adults who have received an FDA-cleared or approved restor3d patient-specific orthopedic implant. Using a master protocol framework, the study enrolls patients across multiple joint cohorts (knee, hip, foot \& ankle, shoulder) under a single protocol, with joint-specific details governed by individual appendices. Participants self-enroll and complete electronic PRO surveys (ePROs) before surgery and at 6 weeks, 3 months, 6 months, and annually through 5 years post-operatively, all remotely, with no required in-person visits. The study aims to quantify changes in pain, function, quality of life, and satisfaction over time, and to establish real-world outcome benchmarks for patient-specific orthopedic implants.

Вмешательства

  • Устройство Patient-Specific Orthopedic Implant
    FDA-cleared or approved patient-specific orthopedic implant manufactured by restor3d, Inc. Implants are individually designed using patient imaging data and 3D-printing technology to match the patient's unique anatomy. This study does not involve any experimental procedures; implantation occurs as part of standard clinical care prior to and independent of study enrollment.

Первичные конечные точки

  • Patient-Reported Implant Survivorship (all cohorts) [Срок оценки: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)]
Вторичные конечные точки (7)
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6a Score (all cohorts) [Срок оценки: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)]
  • Hospital Stay (all cohorts) [Срок оценки: 6 weeks post-operatively]
  • Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, Jr) Score (Knee cohort) [Срок оценки: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)]
  • Change in Ankle Osteoarthritis Scale (AOS) Score (Foot & Ankle cohort) [Срок оценки: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)]
  • Change in Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) Score (Hip cohort) [Срок оценки: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)]
  • Change in Single Assessment Numeric Evaluation (SANE) score (Shoulder cohort) [Срок оценки: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)]
  • Change in American Shoulder and Elbow Surgeons (ASES) score (Shoulder cohort) [Срок оценки: Pre-operative baseline through 5 years post-operatively (assessed at 6 weeks, 3 months, 6 months, 1, 2, 3, 4, and 5 years)]

Критерии участия

Master Protocol Inclusion Criteria:

  • Age ≥ 18 years
  • Prescribed an FDA-cleared or approved orthopedic implant manufactured by restor3d, Inc.

Master Protocol Exclusion Criteria:

  • Patient is receiving an implant not manufactured by restor3d
  • Patient is receiving a restor3d implant that is not FDA-cleared or approved
  • Patient lives outside the United States
  • Patient is receiving a restor3d implant that does not use a patient-specific plan, instrumentation or implant
  • Patient is non-English-speaking
  • Patient is receiving a restor3d implant outside of the defined implant cohorts
  • Patient does not provide informed consent
  • Plus additional cohort-specific exclusion criteria

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07563803 · restor3d-011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗