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Идёт набор NCT05655156

OrthoPureXT Multiligament PMCF Study

Без фазы С лечением Multiligament Knee Injuries

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: OrthoPure XT.
Кому может быть актуально
Состояния в реестре: Multiligament Knee Injuries. 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
Великобритания
Следующий шаг
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Официальное название

Post Market Clinical Follow-Up of OrthoPureXT for the Treatment of Multiligament Injured Knee: a Case Series

Обзор

To monitor residual risks in the post-market phase and to ensure continued clinical evaluation of the device safety and performance to ensure that no new or unexpected risks arise when used during multi-ligament knee reconstructions.

Подробное описание

OrthoPureXT is an acellular, sterile, single use, xenograft (porcine) tissue scaffold that is manufactured using a proprietary decellularisation technology that renders the tissue substantially free from cells, leaving the porcine tissue biocompatible, and safe for implantation into the knee.

28 patients in total to be evenly distributed across potential ligament reconstruction treatment options (n=7 per sub-group) and resulting in a statistically relevant number per sub-group considering potential loss to follow up.

Sub-groups of n=7 incurring ligament reconstruction using OrthoPure XT in the following anatomical locations:

* Posterior cruciate ligament (PCL) * Anterior cruciate ligament (ACL) * Posteromedial corner including the medial collateral ligament (MCL) * Posterolateral corner including the lateral collateral ligament (LCL)

Вмешательства

  • Устройство OrthoPure XT
    Indication: reconstruction of knee ligaments to restore knee function and stability The following device sizes are available for use in this indication: * Size 5 \- Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction) * Size 6 \- Multi-ligament reconstruction (recommended for extra-articular ligament reconstruction) * Size 8 * Primary ACL reconstruction where autograft tissue is not suitable * Revision ACL reconstruction * Multi-ligament reconstr

Первичные конечные точки

  • A change from Baseline in IKDC [Срок оценки: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)]
Вторичные конечные точки (3)
  • A change from Baseline in Lysholm [Срок оценки: Baseline (30 days prior to surgery); 1, 3 ,6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)]
  • A change from Baseline in KOOS [Срок оценки: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)]
  • A change from Baseline in Assessment of Laxity via Physical Examination [Срок оценки: Baseline (30 days prior to surgery); 1, 3, 6 months after surgery (normal clinical follow-up); 12 and 24 months after surgery (long term follow-up)]

Критерии участия

Критерии включения

  • Male and female patients aged 18 years old or above.
  • Adults suffering with multiple knee ligament injuries.
  • Ability to communicate meaningfully with investigative staff, competence to give written informed consent; and willingness and ability to comply with entire study procedures including rehabilitation protocol.

Критерии исключения

  • Those unable to give consent.
  • Those considered as conflicting variables by the investigator. This may include, but is not limited to:
  • Open trauma
  • Neurovascular emergencies
  • Compartment syndrome
  • Life threatening injury
  • Those considered as physical barriers by the investigator, preventing physical or ethical collection of study data. This may include, but is not limited to:
  • Associated fractures that require external fixators
  • Local severe concomitant injuries
  • Injuries to other parts of the body associated with a high level of daily activity/intervention for the patient
  • Those considered as a poor candidate for surgery by the investigator.
  • If female and of child-bearing potential must not have a positive pregnancy test at Visit

1 nor have a stated intention to become pregnant in the next 12 months.

  • Those patients contraindicated for in the IFU, i.e.:
  • Showing signs of infection within 24 hours prior to surgery
  • Patients with known allergy, hypersensitivity, or religious objection to, implanted porcine material
  • Patients unable or unwilling to follow the post-operative care and rehabilitation programme

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Великобритания · 1 центр
  • Royal Stoke University Hospital — Stoke-on-Trent

Идентификаторы

NCT: NCT05655156 · A03/0028/P01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗