ChronOS Stability Study: For Metastatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Achievement of durable posterolateral fusion
研究概览
简要总结
This pilot clinical trial studies beta-tricalcium phosphate bone graft in treating patients undergoing surgery for metastatic spine cancer. A bone graft may help healing and bone growth in patients undergoing surgery for spine cancer
详细描述
OBJECTIVES: I. To determine if Chronos (beta-tricalcium phosphate bone graft) will form a posterolateral fusion mass in patients undergoing fusion surgery for spine cancer within 12 months. II. To evaluate quality of life following the use of ChronOS as measured by (a) pain (or lack of pain) associated with pseudoarthrosis and (b) the need for additional treatment for instability as a result of hardware failure. OUTLINE: Patients undergo placement of beta-tricalcium phosphate bone graft strips posterolaterally during surgery. After completion of study treatment, patients are followed up at 1 month and then every 3 months for 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing surgery for spinal decompression for tatic spine cancer who require bone substitute for a posterolateral spinal fusion
- •Patients may or may not have posterolateral instrumentation
排除标准
- •Status-post previous fusion with allogeneic bone graft
结局指标
主要结局
Achievement of durable posterolateral fusion
时间窗: Within 12 months
Measured from x-ray and/or computed tomography (CT) scans. Standard criteria of determining fusion is visualization of continuous trabeculating bone bridging the transverse processes and facets on AP and lateral x-rays or when there is \< 2 degree angular motion and \< 2mm of translation on standing flexion and extension radiographs.
次要结局
- Achievement of posterolateral fusion(Up to 12 months)
- Occurrence of subsequent hardware failure(Every 3 months for 12 months)
- Requirement of additional treatment is for instability(Within 12 months)
- First documentation of posterolateral fusion(Within 12 months)
- Occurrence of pain or disability experienced after surgery that is related to spinal metastasis or is a consequence of the resulting treatment(Every 3 months for 12 months)