Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities

Официальное название

Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial

Обзор

Evaluation of the Safety and Efficacy of Artificial Bone Repair Materials for Repair of Long Bone Defects in the Extremities: A Prospective, Randomized Controlled, Single-Blind, Non-Inferiority Clinical Trial

Вмешательства

• Устройство Intervention Group:Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.
  Use of artificial bone repair materials produced by Changzhou Bone-Renewal Medical Technologies LLC.
• Устройство Control group: Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.
  Use of β-tricalcium phosphate bioceramics produced by Shanghai Biolu Biomaterials Co., Ltd.

Первичные конечные точки

• Bone graft fusion rate [Срок оценки: 24weeks after surgery]

Вторичные конечные точки (3)

• Bone defect healing rate [Срок оценки: 4 and 12 weeks after surgery]
• New bone formation rate [Срок оценки: 4, 12 and 24 weeks after surgery]
• SF-36 scale [Срок оценки: 24 weeks after surgery]

Критерии участия

Критерии включения

• Age ≥ 18 years old and ≤ 60 years old, regardless of sex;
• Cavitary bone defects in the limbs requiring bone grafting treatment;
• Bone defect volume ≥ 1 cm³ and ≤ 8 cm³, with only one bone defect requiring intervention;
• Subjects or their legal guardians can understand the study objectives, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.

Критерии исключения

• Open fractures with wound contamination;
• Repair of infectious bone defects;
• Structural bone grafting required at the defect site;
• Osteofascial compartment syndrome in the affected limb scheduled for surgery;
• Presence of systemic infection, uncontrolled local infection at the surgical site, malignant tumor (including metastatic tumors) at the defect site, osteonecrosis at the defect site, severe nerve/soft tissue/vascular injury at the defect site, confirmed severe malnutrition, or dysfunction/failure of other vital organs;
• Calcium and phosphorus metabolic abnormalities (calcium/phosphorus levels > 1.5 times the upper limit of normal values);
• History of diabetes with fasting blood glucose ≥ 6.1 mmol/L;
• Coagulation dysfunction (prothrombin time \[PT\] or activated partial thromboplastin time \[APTT\] > 2 times the upper limit of normal values);
• Use of chemotherapeutic agents or receipt of radiotherapy within 3 months prior to enrollment;
• Cumulative use of corticosteroids or growth factors for ≥ 14 days within 1 month prior to enrollment;
• Long-term use of sedative-hypnotic drugs (continuous use for > 3 months) or non-steroidal anti-inflammatory drugs (NSAIDs, continuous use for > 3 months);
• Known allergy to bovine-derived materials or collagen products;
• Pregnant or lactating females;
• Participation in other interventional clinical trials for drugs or medical devices within 1 month prior to enrollment;
• Any other conditions where investigators, in their professional judgment, deem the subject ineligible to participate in the trial for the subject's safety or benefit.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Chinese PLA General Hosptial — Пекин

Идентификаторы

NCT: NCT06959459 · 2024QX008-KS002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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