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临床试验/NCT02372825
NCT02372825已完成不适用

Role of Free Iliac Crest Flap in Heel and Ankle Reconstruction

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
The 15-Dimensions (15D) health-related quality of life (HRQoL) instrument

研究概览

简要总结

Treatment of extensive traumatic acute bone defects or sequela in heel or ankle poses a formidable challenge for the reconstructive surgeon. These defects can be treated with the vascularized iliac crest transfer. The purpose of this study is to assess the reliability and the long-term outcomes of free iliac crest flap transfer for these indications.

详细描述

Thirteen patients were included in this study. Data was collected retrospectively from the patient records. The study design included three outcome measures to assess the clinical long-term outcomes. These were the Visual Analogue Scale Foot and Ankle (VAS FA), the Oswestry Disability Index (ODI), and the 15-dimensions (15D) health-related quality of life (HRQoL) instrument. The data was collected with postal approach and a written informed consent obtained from the seven participants.

研究设计

研究类型
Observational
时间视角
Cross Sectional

入排标准

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

入选标准

  • Patients with acute defects or sequela in the heel or ankle treated with the vascularized iliac crest transfer.

排除标准

  • Patients without treatment with the vascularized iliac crest transfer,
  • Exclusion criteria for the cross-sectional assessment:
  • below-knee amputation,
  • permanent non-union

结局指标

主要结局

The 15-Dimensions (15D) health-related quality of life (HRQoL) instrument

时间窗: 2-26 years

Assesses the HRQoL

Visual Analogue Scale Heel and Ankle (VAS FA)

时间窗: 2-26 years

Assesses the function of the heel and ankle

Oswestry Disability Index (ODI)

时间窗: 2-16 years

Assesses the function of the donor site

次要结局

未报告次要终点

研究者

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

Jussi Repo

Researcher

Helsinki University Central Hospital

研究点 (1)

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