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临床试验/NCT02265991
NCT02265991已完成不适用

Prospective Biomechanical Analysis of Donor-site Morbidity Following Microvascular Fibula Transplantation in 27 Consecutive Cases: a Clinical Cohort Study.

Universitätsklinikum Hamburg-Eppendorf0 个研究点目标入组 27 人开始时间: 2011年9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
27
主要终点
Change in Esslinger Fitness Index

研究概览

简要总结

Pre- and postoperatively patients who underwent free fibula flap were examined regarding donor-site morbidity of the lower extremities.

详细描述

27 patients are examined before and after microsurgical fibula flap performed at the Department of Oral and Maxillofacial Surgery, University Medical Center Hamburg Eppendorf, Germany.

研究设计

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

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

  • Planned continuity interrupting mandible resection
  • Planned mandible reconstruction with free fibula flap
  • Informed consent
  • Procedure performed at University Medical Center Hamburg Eppendorf

排除标准

  • Preexisting pathology/disease of the lower limbs or back (angiologic, neurologic, orthopedic)
  • Musculosceletal pain at the time of study enrollment

结局指标

主要结局

Change in Esslinger Fitness Index

时间窗: 1 day before fibula transplantation and 8.3 months postoperatively on average

Jumping Mechanography, Functional Assessment on Leonardo Mechanograph GFRP

次要结局

  • Range of Motion(1 day before fibula transplantation and 8.3 months postoperatively on average)
  • AOFAS Score(1 day before fibula transplantation and 8.3 months postoperatively on average)
  • Balance Test(1 day before fibula transplantation and 8.3 months postoperatively on average)

研究者

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

Carsten Rendenbach

Resident, Researcher

Universitätsklinikum Hamburg-Eppendorf

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