Prospective Bone Metastases Database
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction
研究概览
简要总结
The aims of this study are to collect prospective data on the natural history of bone metastases (BMs) and skeleta related events (SREs),
详细描述
The aims of this study are to evaluate clinical and biological factors of patients with BMs after reconstruction with intramedullary fixation (IMN) or endoprosthetic reconstruction (EPR) with a specific focus on (1) the rate of complication or failure; (2) differences in complication rates by anatomic site; (3) functional results as assessed by the Musculoskeletal Tumor Society System (MSTS); (4) differences in complication rate between patients treated with INM versus EPR; and (5) differences in survival in patients with metastatic bone disease based on disease-specific, laboratory, and demographic information.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with long bone metastases treated surgically with intramedullary nail or endoprosthetic reconstruction
排除标准
- •Patients with bone metastases of the spine
结局指标
主要结局
Clinical outcomes after treatment of long bone metastases with intramedullary nail versus endoprosthetic reconstruction
时间窗: 24 months
The study includes the collection of clinical data (age, sex, Karnofsky score) and laboratory data related to the patient (erythrocyte sedimentation rate, C reactive protein, Alkaline phosphatase, white blood cells and hemoglobin) at the time of admission, data on the pathology (histotype, site of bone metastasis , presence of further skeletal or visceral metastases), type of surgery performed (stabilization versus resection).The objectives of this study is to examine clinical outcomes after after surgical treatment of bone metastases with a specific focus on differences in complication rate between patients treated with intramedullary nail versus endoprosthetic reconstruction
次要结局
- Survival in patients undergoing surgery for metastatic bone disease(24 months)
研究者
Costantino Errani
MD, PhD.
Istituto Ortopedico Rizzoli