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临床试验/NCT03188926
NCT03188926已完成不适用

Surgical Treatment for Long Bone Metastases With Intramedullary Nail or Endoprosthetic Reconstruction

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年1月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
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

To provide treatment guidelines for patients with long bone metastatic disease based on observational study and to propose an algorithm to guide orthopedic surgeons in decision-making for these patient.

详细描述

The objectives of this study were to examine clinical outcomes 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

入选标准

  • bone metastases of the extremity

排除标准

  • 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: 1 year

The objectives of this study were to examine clinical outcomes after reconstruction with intramedullary nail versus endoprosthetic reconstruction 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(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Costantino Errani

MD, PhD

Istituto Ortopedico Rizzoli

研究点 (1)

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