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Идёт набор NCT06428448

Study to Evaluate the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections

Фаза II С лечением Periprosthetic Joint Infection

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: REMEDY Spectrum IM Spacer Nail.
Кому может быть актуально
Состояния в реестре: Periprosthetic Joint Infection. Базовые параметры: от 21 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

A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of the REMEDY SPECTRUM GV IM Spacer Nail in the Treatment of Ankle-Related Infections

Обзор

This study is being conducted to evaluate the safety and effectiveness of the REMEDY SPECTRUM IM Spacer Nail in the treatment of ankle-related infections. The study is expected to take approximately 18 months from first subject enrolled to the last follow-up visit. It will have a 12-month enrollment period and a 6-month follow-up. This study is a Prospective, multicenter, single-arm clinical trial. All subjects enrolled in this study will receive the REMEDY SPECTRUM IM Spacer Nail.

Вмешательства

  • Комбинированный продукт REMEDY Spectrum IM Spacer Nail
    The REMEDY SPECTRUM IM Spacer Nail is a single-use implant made of polymethylmethacrylate (PMMA) which is internally reinforced with a stainless-steel core (ASTM F138, ISO 5832-1). The PMMA of the REMEDY SPECTRUM IM Spacer Nail is laden with gentamicin and vancomycin. The nail has a slot at the distal end and can be combined with the surgeon's choice of fixation to prevent migration depending on the anatomy of the patient. The REMEDY SPECTRUM IM Spacer Nail is available in two lengths (150mm an

Первичные конечные точки

  • Successful Treatment of Infection Based on Lab Values and Culture [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Be ≥ 21 years of age
  • Have an ankle-related infection
  • Is skeletally mature, as evidenced by closed epiphyses.
  • Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
  • Be willing and able to comply with all study procedures including all pre-operative, post-operative requirements
  • If female and of child-bearing potential, must have a negative pregnancy test prior to the surgical procedure and no intention of becoming pregnant until study completion.

Критерии исключения

  • Infections that do not involve the ankle
  • Have a known immunodeficiency; including subjects who are receiving or have received immunosuppressants, immunostimulating agents or radiation therapy within 6 months prior to surgery
  • Affected limb is dysvascular
  • Where adequate soft-tissue coverage cannot be achieved
  • Have any mental or psychological disorder that would impair their ability to complete the study questionnaires
  • Are currently pregnant or breastfeeding, or planning to become pregnant or breastfeed any time during the course of the study
  • Are currently a prisoner
  • Have any medical condition or other circumstances, in the judgment of the Investigator, that might interfere with the ability to return for follow-up visits, including any systemic illness, neuromuscular, neurosensory, or musculoskeletal deficiency that would render the subject unable to perform appropriate post-operative activities.
  • History of vancomycin or gentamicin allergy
  • Are implanted with other antibiotic eluting products.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 3 центра
  • University of Michigan Health - Sparrow Clinical Research Institute — Lansing
  • OrthoCarolina Research Institute — Charlotte
  • Duke University Medical Center — Durham

Идентификаторы

NCT: NCT06428448 · OR-SN-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗