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临床试验/NCT06382792
NCT06382792Enrolling By Invitation不适用

Results of Proximal Humeral Reconstruction With Allograft Prosthetic Composite After Resection for Tumors

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
6
试验地点
1
主要终点
Osteolysis (bone stock in cm3)

研究概览

简要总结

The gold standard after shoulder resection for tumors is reconstruction by reverse prosthesis and allograft. This is an intervention also performed for more frequent etiologies (revisions of prosthesis, non cancerous humeral bone loss ...).

The results in these etiologies are good, and do not find any particular mechanical complications (including no osteolysis of the graft). In the case of reconstruction for cancer, the numbers of patients are lower (rare pathologies) and some studies on small numbers found osteolysis of the allograft. The aim of this study is to analyze the presence or not osteolysis in these patients, and to quantify it precisely by scanner measurement (no data yet in the literature).

详细描述

quantify bone stock of the allograft by scanner measurement in post operative and in 6 month to 1 years after surgery.

This is a retrospective study, and the scanner was performed routinely every 3 to 6 month, during 2 years, for oncological follow up.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • tumors of proximal humerus
  • Malawer type I resection
  • primary reconstruction by allograft prosthetic composite

排除标准

  • resection and reconstruction by prosthesis alone
  • resection and reconstruction by prosthesis and cement sleeve reconstruction
  • resection and reconstruction by hemiarthroplasty
  • revision protheses.

结局指标

主要结局

Osteolysis (bone stock in cm3)

时间窗: within 3 months post operatively and up to 1 year post operatively

allograft bone stock by scanographic measurements after the surgery, and at minimum 6 month follow up

次要结局

  • Constant score(up to 1year post operatively)
  • Complications(up to 1year post operatively)
  • Revision(up to 1year post operatively)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

PEDUZZI Lisa

Principal Investigator

Central Hospital, Nancy, France

研究点 (1)

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