NCT07540468尚未招募不适用
Safety Evaluation of Bioactive Glass-Based Bone Cement Combined With Ultrasound in Implantation for Metastatic Bone Tumors
Liao Yun0 个研究点目标入组 8 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8
- 主要终点
- Adverse Event/Adverse Reaction Incidence Rate
研究概览
简要总结
This study is evaluating the safety of using bioactive glass-containing bone cement combined with ultrasound during surgery for patients with metastatic bone tumors. We aim to see if this treatment can be safely applied to stabilize the bone and reduce pain, without causing unexpected side effects. All participants will receive standard care plus the study treatment, and we will closely monitor them during and after the procedure to check for any safety concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age between 18 and 80 years (inclusive), regardless of gender;
- •Patients with advanced cancer, presenting with intractable pain due to clinically, radiologically and pathologically confirmed pelvic metastases;
- •Osteolytic lesions primarily located in the periacetabular or non-periacetabular regions;
- •Expected survival of more than 1 year;
- •Voluntarily agree to participate in this clinical trial, and the subject and/or their legal guardian is willing and able to provide written informed consent;
- •Demonstrates good compliance, is willing to follow medical advice, and is able to attend all required follow-up visits as specified in the protocol.
排除标准
- •1. Relative surgical contraindications, such as pelvic discontinuity or fracture displacement > 5 mm;
- •Poor general health status with an estimated survival of less than 3 months;
- •Destruction of the inner iliac cortex associated with soft tissue masses affecting vital organs, nerves, or blood vessels;
- •Presence of active systemic infection;
- •Previous history of bone cement injection at the target lesion site;
- •Severe hepatic or renal dysfunction (Child-Pugh class C, eGFR < 30 mL/min);
- •Coagulopathy or bleeding diathesis;
- •Known hypersensitivity or allergy to bone cement components;
- •Poor adherence, unwilling or unable to comply with postoperative treatment and/or rehabilitation regimens;
- •Patients who are mentally incompetent or unable to understand the requirements of study participation;
- •Unable to attend follow-up visits at the study institution;
- •Participation in another clinical trial within 3 months prior to enrollment in this study;
- •Pregnant or breastfeeding women.
研究组 & 干预措施
BG-Bone Cement + Ultrasound Treatment Group
Experimental
干预措施: Bioactive Glass Bone Cement + Ultrasound (Other)
结局指标
主要结局
Adverse Event/Adverse Reaction Incidence Rate
时间窗: 12 months postoperatively
次要结局
未报告次要终点
研究者
Liao Yun
Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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