Zoledronic Acid-loaded Bone Cement as a Local Adjuvant Therapy for Giant Cell Bone Tumor After Intralesional Curettage: a Prospective, Multicenter, Single Blinded, Randomized Control Trial.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- time to first local recurrence
研究概览
简要总结
The purpose of this study is to investigate whether zoledronic acid-loaded bone cement (4mg ZOL+ gentamicin PMMA ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. The hypothesis is that patients with local administration of zoledronic acid to the bone cement has lower relapse rate compared those with traditional bone cement(gentamicin PMMA ).
详细描述
The purpose of the clinical study is to investigate whether the local delivery of zoledronic acid (4mg ZOL-loaded gentamicin PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will also evaluate whether patients with zoledronic acid as a surgical adjuvant improves secondary outcomes, including function (MSTS and TESS), surgery related complications (henderson's failure mode) and ZOL-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with primary resectable GCT of bone
- •lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal
- •no previous systemic bisphosphonate or denosumab therapy
- •with expected longer than 18 months of survival time
- •sign the informed consent form
排除标准
- •patients with recurrent GCT or extensive GCT which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature.
- •conduct unexpected surgery at other center
- •the primary goal for surgery is revision
- •patient conduct en-bloc/wide resection instead of curettage surgery
- •patient can not conduct self-assessment during follow up
- •difficulty in complete postoperative follow-up
- •previous use of bisphosphonate/ZOL or denosumab drug
- •patients have participated in similar research projects
- •refused to sign informed consent
结局指标
主要结局
time to first local recurrence
时间窗: All patients will be followed for this endpoint until 18 months postoperatively
Time to first local recurrence will be reported during postoperative 18-month follow up period
次要结局
- Potential ZOL-related complications(Patients will be followed to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively.)
- MSTS score(Doctors will be responsible in filling this questionnaire 3 months, 9 months, 12 months, 18 months postoperatively during patients' follow up)
- postoperative complication(Patients will be asked to report any complication 1 month, 3 months, 6 months, 9 months, 12 months, 18 months postoperatively during follow up)
- TESS score(Patients will be asked to fill this survey 3 months, 9 months, 12 months, 18 months postoperatively)