Using the Boneflo System During Orthopedic and Trauma Surgery: A Prospective Multicenter Study (BoneFlo)
Analysis of the Intraoperative Use and Handling of the Boneflo Tissue Collector System in Orthopedic and Trauma Surgery
Critical bone defects, non-unions, and delayed bone healing remain major challenges in orthopedic and trauma surgery and often require bone grafting. While a patient's own bone (autograft) is considered the gold standard, its use is limited by donor-site morbidity and limited availability. Synthetic bone substitutes offer an alternative but mainly provide structural support and lack biological activity.
This prospective multicenter pilot study evaluates the safety and feasibility of using the Boneflo® Tissue Collector System to biologically activate bone substitutes during surgery. The device collects the patient's own tissue, blood, and biologically active factors directly from the surgical site using a vacuum-assisted suction system with an integrated filter. This material is then used intraoperatively to coat and bioactivate bone substitute materials.
In healing attempts, 50 patients with critical bone defects, non-unions, or impaired bone healing were treated across four centers. Various bone substitutes, including synthetic calcium phosphate materials, collagen-based scaffolds, and allografts, were used.
The primary aim of the study was to evaluate device safety, intraoperative usability, handling, and applicability for coating and activating bone substitutes. The device was evaluated by orthopedic surgeons and other medical professionals, including nurses, physician assistants, and technical assistants.
Furthermore, these data were supplemented with clinical outcome data from healing attempts, including wound healing and radiographic bone regeneration, assessed over a minimum six-month follow-up period.
Обзор исследования
Статус
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Mülheim, Германия, 45468
- St. Marien-Hospital Mülheim an der Ruhr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
Patients with critical size bone defects, non-unions or delayed bone healing
Indication for bone grafting (autologous, allogeneic, or synthetic)
Age ≥ 18 years
Written informed consent obtained prior to surgery
Ability to comply with follow-up visits for at least 6 months
Exclusion Criteria:
Active local or systemic infection
Vertebral body defects (according to device instructions for use)
Active malignancy or tumor-related bone disease
Severe systemic disease affecting bone healing (e.g., autoimmune disease, immunodeficiency)
Contraindication to surgery or anesthesia
Inability or unwillingness to provide informed consent
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Другой: Bioactivated Bone Substitutes Using a Surgical Suction Device
Synthetic bone substitutes were intraoperatively activated using autologous tissue in patients with critical bone defects, non-unions, and delayed bone healing.
During surgery, autologous tissue, blood, and biologically active components were collected from the surgical site under vacuum conditions using an integrated filter system.
The collected material was used to coat and biologically activate bone substitutes, including calcium phosphate ceramics, collagen-based scaffolds, and allografts.
The primary focus was on safety, intraoperative usability, handling, and applicability of the device for bone substitute bioactivation.
These data were combined with clinical outcomes in healing attempts, including wound healing and radiographic bone regeneration over a six-month follow-up period.
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During surgery, autologous tissue, blood, and biologically active components are collected from the surgical site under vacuum conditions with an integrated filter system using the BoneFlo tissue collector.
The collected autologous material is used to coat and biologically enhance bone substitutes.
Bone substitutes include calcium phosphate ceramics, collagen-based scaffolds, and allografts.
This intervention is performed intraoperatively and aims to improve the biological activity of otherwise mainly osteoconductive materials.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of device-related adverse events (% of participants)
Временное ограничение: Up to 30 days postoperatively
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Assessment of safety of the surgical suction device used for intraoperative bioactivation of bone substitutes, measured by the number and proportion of participants experiencing device-related adverse events, as recorded in clinical evaluation and adverse event reporting.
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Up to 30 days postoperatively
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Surgeon-reported usability score (Likert scale)
Временное ограничение: Immediately after the procedure
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Assessment of device applicability and handling using a standardized surgeon questionnaire with a Likert scale rating immediately after use.
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Immediately after the procedure
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Rate of successful intraoperative bioactivation procedures
Временное ограничение: Intraoperatively (during the index surgical procedure)
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Assessment of intraoperative feasibility based on successful completion of the procedure as judged by the operating surgeon.
The unit of measure is the percentage of procedures (% of procedures).
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Intraoperatively (during the index surgical procedure)
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BO/35/2025-Studie-01 (Другой идентификатор: Ärztekammer Niedersachsen (Ethics Committee))
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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