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Идёт набор NCT05169229

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement.

Фаза II С лечением Arthroplasty, Replacement, Hip Osteoarthritis, Hip Antibiotic Resistant Infection Prosthetic 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: Vancomycin + Tobramycin, Saline.
Кому может быть актуально
Состояния в реестре: Arthroplasty, Replacement, Hip, Osteoarthritis, Hip, Antibiotic Resistant Infection, Prosthetic Joint Infection. 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
Швеция
Следующий шаг
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Официальное название

Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial

Обзор

Total hip replacement is the most successful treatment modern healthcare can offer patients to regain quality of life. Periprosthetic joint infection (PJI) is the most common and devastating complication after total hip replacement (THR). Between 0.5 to 2% of primary THR (first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis) will become infected.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities. The number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement is urgent. Impacted morselized bone allograft is often used in (revision) THR to fill bone defects. Morselized allograft has been used as a carrier for local antibiotic treatment in multiple pilot studies and appears to be an attractive and effective treatment option, both for already infected joints and as a prophylactic measure in high-risk patients (e.g. THR revision surgeries). Nonetheless, a pivotal trial to support its use in THR is lacking. The aim of this pragmatic randomized controlled double blinded drug trial is to investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective THR will be randomized to receive AIBG or a placebo impregnated bone graft. The primary outcome variable will be the number of re-operations due to infections and PJI diagnoses 2 years postoperative.

Вмешательства

  • Препарат Vancomycin + Tobramycin
    1 g vancomycin (powder) diluted in 8 ml tobramycin (40 -80mg/ml). Added to the prepared allograft before the allograft is used during the revision surgery.
  • Препарат Saline
    As a placebo added to the allograft.

Первичные конечные точки

  • Time to reoperation due to infection or diagnosed PJI with bacteria that are sensitive to either vancomycin or tobramycin, in the same hip joint, within two years after hip arthroplasty. [Срок оценки: 2 years after finalizing data collection.]
Вторичные конечные точки (4)
  • Time to reoperation due to infection or diagnosis of PJI with any microorganism in the same hip joint within 2 years after THA. [Срок оценки: All infections within 2 years after index surgery.]
  • Time to and cause for reoperation for any reason within 2 and 5 years [Срок оценки: 2 and 5 years after finalizing data collection.]
  • Time to and cause for implant revision due to any reason within 2 and 5 years [Срок оценки: 2 and 5 years after finalizing data collection.]
  • Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection [Срок оценки: 2 and 5 years after finalizing data collection.]

Критерии участия

Критерии включения

  • Age ≥ 18 years
  • Hip arthroplasty requiring bone graft
  • Willing to provide informed consent.
  • For women of childbearing potential; a negative pregnancy test prior to surgery.

Критерии исключения

  • Ongoing prosthetic joint infection
  • Known allergies and contraindications for the use of vancomycin or tobramycin
  • Mental inability, reluctance, or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
  • Expected difficulties to complete 2-year follow-up
  • Females of child bearing potential not using contraception
  • Pregnant females
  • Nursing females

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Четверное слепое
Основная цель
Лечение

Центры проведения

Швеция · 1 центр
  • Universitetssjukhuset Linköping — Linköping

Идентификаторы

NCT: NCT05169229 · ABOGRAFT-01 · 2024-510921-25-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗