Идёт набор NCT06156904

OSsIRIS Study - A Post-market Clinical Follow-up Investigation.

— Наблюдательное Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury

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: Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities..
Кому может быть актуально: Состояния в реестре: Surgically Created Bone Defects or Bone Defects/Voids Resulting From Traumatic Injury. 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: Германия, Великобритания
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 Post-market Clinical Follow-up Investigation to Confirm the Performance and Safety of the Bone Substitute b.Bone in Extremities and Pelvis.

Обзор

This is a prospective, observational, non-randomized, multicenter, international post-market clinical follow-up investigation aiming to confirm the performance and safety of the bone substitute b.Bone after implantation in patients in isolation or as a graft expander requiring bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities. Patients enrolled in this clinical investigation will undergo orthopaedic surgery with b.Bone as recommended by the specialist and according to orthopaedic standard procedures. Patients will be evaluated preoperatively and at different time points after the surgery according to the standard practice of the sites. The expected schedule is at month 3, month 6 and month 12. Patients who require longer follow-up and could be subjected to metalwork removal will be evaluated up to 24 months. All safety data will be collected from patient inclusion to the end of the clinical investigation. All study visits will coincide with any of the patient's routine clinical visits, without interfering with the investigator's clinical duties. It is planned to enroll 135-193 patients from approximately 15 EU and UK sites.

Вмешательства

Устройство Bone grafting for the treatment of surgically created bone defects or bone defects/voids resulting from traumatic injury to promote healing in the pelvis, upper and lower extremities.
All patients enrolled in this clinical investigation will undergo a reconstruction of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone as per the standard of care at the investigational sites. Patients will be treated with b.Bone which will be used as a bone substitute in isolation or as a graft expander to promote healing in the pelvis, upper and lower extremities. b.Bone is a bone substitute without initial mechanical properties, therefore it i

Первичные конечные точки

Performance of b.Bone by determining the radiographic healing/union after surgery. [Срок оценки: 12 months]

Вторичные конечные точки (4)

Clinical outcomes measured by patient-reported outcomes - Pain [Срок оценки: Baseline and 3, 6 and 12 months]
Clinical outcomes measured by patient-reported outcomes - Quality of Life [Срок оценки: Baseline and 3, 6 and 12 months]
Evaluate the safety of b.Bone during the clinical investigation period - AE and SAE [Срок оценки: Up to 24 months]
Evaluate the safety of b.Bone during the clinical investigation period - rate of reinterventions [Срок оценки: Up to 24 months]

Критерии участия

Критерии включения

Patient is undergoing a standard of care bone grafting with b.Bone for the treatment of surgically created bone defects or bone defects resulting from traumatic injury in the extremities and pelvis according to the approved IFU.
Male or female patient ≥ 18 years old.
Patients willing and able to attend the standard of care follow-up visits and procedures.
Patients who have provided consent to participate in the clinical investigation and to the processing of personal data.

Критерии исключения

Patients with any conditions in which b.Bone is not indicated according to the contraindications defined in the IFU of b.Bone
Patients who are currently enrolled in another clinical investigation/study that would directly interfere with the current clinical investigation, except when the patient is participating in a purely observational study with no associated treatments.
Woman who is pregnant or breast-feeding.
Patients who, in the opinion of the Investigator, have an existing condition that could affect their ability to complete patient reported questionnaires or be compliant with the standard of care follow-up visits and examinations for the duration of the clinical investigation.

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

Здоровые добровольцы: Нет