CTRI/2023/10/058286招募中2 期
A Multi-Center, Prospective, Open-Label, Assessor-Blinded, Randomised, Controlled, Non-Inferiority, Pivotal Clinical Investigation to evaluate the Performance and Safety of 3-D Scaffold Matrix – a Class C Medical Device Bone Void Filler as a Bone Graft Substitute in Orthopaedic Surgery - NI
EffecMed Pvt. Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1 Patients between the age of 18 and 65 years both inclusive with any of the following
- •a. Requiring bone grafting after post-traumatic or surgically created bone defects afflicting the long bones and extremities.
- •b. Gap defects 6mm and 25 mm
- •c. Traumatic, open and closed fracture
- •d. Open and closed fractures - traumatic, closed, depression fracture of the proximal tibia (limited to AO type B2 and B3)
- •e. Cavitary defects in benign and low-grade malignant bone tumours.
- •f. Bone void created during surgery.
- •g. Bone disease i.e. osteogenesis imperfecta, cancer, osteoporosis, Paget disease
- •2. Negative for HIV and HBsAg.
- •3. Written informed consent obtained before any study-related activities.
- •4. Communicative ability to understand the procedure and participate in the study and comply with the follow up.
排除标准
- •Patient will be excluded from the study, if they have any of the following
- •1. Critical size defect below 5 mm
- •2. Critical size defect more than 26 mm
- •3. Polytrauma bone injuries
- •4. Excessive destruction of bone through and through defects, excessive thinning of lower border
- •5. Injury leading to debridement interval more than 12 h
- •6. Compartment syndrome
- •7. Pathologic fracture
- •8. Chronic pain disease
- •9. Malignancy
- •10. Chronic cortisone intake
- •11. Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation
- •12. Pre-existing calcium metabolism disorder Hypercalcemia
- •13. Known hyperthyroidism or autonomous thyroid adenoma
- •14. Irreversible coagulopathy or bleeding disorder
- •15. Metastatic cancer
- •16. Active infection at the site of implantation
- •17. History of bone marrow disorders
- •18. Active malignancy, cellulitis, osteomyelitis, bone metastasis, and other bone metabolic diseases.
- •19.Primary bone tumour and contraindications in performing an Xray or CT scan
- •20. Women of childbearing potential who are, or plan to become, pregnant during the time of the study.
- •21.With known autoimmune disease, such as Addison disease, Myasthenia gravis, Pernicious anaemia, Reactive arthritis, Rheumatoid arthritis, Sjogren syndrome, Systemic lupus erythematosus, Dermatomyositis, Grave disease, Hashimotos thyroiditis, and Type 1 diabetes mellitus.
- •22. Physical or psychological condition that contraindicates the use of an investigational device or render the patient at high risk from treatment complications.
- •23. Concurrently participating in other clinical trials or within last 1 month.
研究者
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