CTRI/2022/07/044291招募中未知
A prospective, single-centre, non- randomised pilot clinical study to evaluate the safety and efficacyof biodegradable NANOTEX BONE graft (Nanocomposite Fibrous Scaffold) along with fibula flap inreconstruction of segmental mandibular defect due to tumour resection or trauma
Amrita Vishwa Vidyapeetham Amrita Institute of Medical Sciences0 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
- 未知
- 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 must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- •2.Segmental Mandibular defect due to resection of benign tumour or trauma
- •3.A female patient is eligible to participate if she is not pregnant, not breastfeeding
- •4.Patient must be available at the study centre for all specified assessments throughout the study duration.
- •5.Patients whose clinical laboratory test results are within the reference range for healthy individuals, or where outside the reference range is judged as not clinically relevant by the Investigator
排除标准
- •-Uncontrolled alcohol, tobacco, or substance abuse within 6 months prior to implantation.
- •-Mandibular ramus defects with open wounds.
- •-Systemic disease that would affect the surgical procedure and implant integration along with associated anesthesia, unsafe to the patient.
- •-Patient has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would impact patient safety or interfere with the integrity of the study data
- •-Active uncontrolled infection or malignancy.
- •-Patients indicated for radiotherapy before and after surgery
- •-Patients participated in any other clinical trial in past 1 month, or currently participating in any other clinical trial.
- •-Conditions that may impact the success of the surgical implantation or increase the risk of postoperative complications, including inherited coagulopathies like hemophilia, Von Wille brand s disease, protein C
- •and S deficiency, thrombocythemias, thallassemias, sickle cell disease, etc.
- •-Conditions that may impact functional outcomes, including uncontrolled diabetes, osteoporosis, rare disorders of bone healing like osteopetrosis, or any other metabolic bone disease.
- •-Increased alkaline phosphatase (to exclude Paget s disease), increased serum calcium (to exclude hyperparathyroidism), or Vitamin D deficiency, at Screening, confirmed by a repeat test.
- •-Oral bisphosphonate < 12 weeks, intravenous bisphosphonate < 12 months prior to Screening or use of systemic steroids or anabolic agents (e.g. teriparatide) for osteoporosis treatment.
- •-Mixed connective tissue diseases and collagen diseases which can result
- •in poor wound healing after surgery.
- •-Patients participated in any other clinical trial in past 1 month, or currently participating in any other clinical trial. .
研究者
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