Local Bisphosphonate Effect on Recurrence Rate in Extremity Giant Cell Tumor of Bone: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 32
- 主要终点
- The endpoint for patient participation will be local recurrence
研究概览
简要总结
The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate as a surgical adjuvant can decrease the chance of a giant cell tumor of bone coming back to the same location. The hypothesis is that the local administration of bisphosphonate will decrease the rate of the tumor returning compared to traditional aggressive surgical removal of the tumor.
详细描述
The purpose of the clinical study is to investigate whether the local delivery of bisphosphonate (BP-loaded PMMA bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (GCT) of bone. The investigators will evaluate whether bisphosphonate as a surgical adjuvant improves secondary outcomes, such as pain, function, fever, or wound complications. The hypothesis is that the local administration of bisphosphonate will decrease the recurrence rate of GCT compared to traditional aggressive intralesional curettage.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary benign GCT of bone
- •Lesion located in an extremity
- •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
排除标准
- •Recurrent GCT of bone
- •Non-extremity location
- •Lesion too extensive for intralesional treatment, either due to bone loss, joint invasion, or large soft tissue component
- •Children and pregnancy
- •Previous systemic bisphosphonate or denosumab therapy
研究组 & 干预措施
Control group
The surgical procedure for all patients will include extensive curettage of the lesion to remove macroscopic tumor, high-speed burring of the residual cavity, adjuvant treatment to the residual cavity, followed by packing of the cavity with either polymethylmethacrylate (PMMA) bone cement (Simplex P; Stryker, Mahwah, New Jersey) alone or bone cement with subchondral allograft bone graft. The choice of cavity reconstruction will be at the discretion of the treating surgeon. Traditional local adjuvants (argon beam coagulation, phenol, ethanol, or cryotherapy) will be used depending on surgeon preference. In addition to the above standard treatment, the patients will be randomized into one of two study arms. In Arm 1, the control group, no additional local therapy will be utilized.
Bisphosphonate group
In Arm 2, the bisphosphonate group, 4 mg of zoledronic acid (Zometa) will be added to each bag of bone cement.
干预措施: Zoledronic Acid (Drug)
结局指标
主要结局
The endpoint for patient participation will be local recurrence
时间窗: Followed for 2 years postoperatively for study end points
Local recurrence of giant cell tumor of bone
次要结局
- Surgical site infection(Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.)
- Wound healing(Follow-ups will consist of clinical visits. The clinical visits will be at 2 weeks postoperatively, 6 weeks postoperatively, and then every three months for the first two years after surgery.)
- MSTS Score(Followed for 2 years postoperatively for study end points)
- Potential bisphosphonate complications related to systemic administration(Followed for 2 years postoperatively for study end points)
研究者
David D. Greenberg, MD; Professor
Professor Orthopaedic Surgery Saint Louis University
St. Louis University