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临床试验/NCT03385694
NCT03385694已完成不适用

Long Term Clinical and Functional Outcome in Patients Operated on Van Ness-Borggreve Rotationplasty for Lower Limnb Bone Tumor

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年11月23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
30
试验地点
1
主要终点
Hip X ray assessment

研究概览

简要总结

Rotationplasty is a very special surgical technique. In its most frequent variant it allows, in the bone sarcomas of the distal femur, to remove all the thigh tissues including the knee joint keeping intact the innervation of the leg and the foot that are transplanted proximally after a 180 ° rotation and joined to the proximal femoral stump.

It is currently the first choice in children under the age of 6 with a bone sarcoma localized to the distal femur but also finds indication in all age groups in cases of extremely voluminous and extended to the entire thigh with the oncological need to remove in block femur, knee and all the muscular involved. The objective of the study is to obtain information about the clinical and functional status of the limb operated in long-term surviving patients. In particular in this study the problem of the possible degenerative pathology of the hip on the operated side will be addressed. Moreover the psychic and psychological well-being of this population with particular reference to gender and motherhood will be tested.

详细描述

30 long term survivors of rotationplasty patients at the IOR will be welcomed by the research team. They will be introduced to the aims of the research and the methodology and timing of the assessment.

The two-day agenda will be communicated to perform in a coordinated manner so that each patient performs all the exams:

  • X ray pelvis
  • Physiatric, orthopedic and prosthetic examination
  • Proprioceptive test with Delos system
  • Psychological questionnaires

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Rotationplasty patients operated at IOR

排除标准

  • Disagreement of patient to participate to the study (or of part of it)

结局指标

主要结局

Hip X ray assessment

时间窗: 4.12.2017 - 3.12.2018

Pelvic frontal X-ray

次要结局

  • Physiatric Assessment(4.12.2017 - 3.12.2018)
  • Well being(4.12.2017 - 3.12.2018)
  • Body Image(4.12.2017 - 3.12.2018)
  • Orthopaedic assessment(4.12.2017 - 3.12.2018)
  • Prostheses Assessment(4.12.2017 - 3.12.2018)
  • Psychological status(4.12.2017 - 3.12.2018)
  • Balance assessment(4.12.2017 - 3.12.2018)
  • Symptoms(4.12.2017 - 3.12.2018)

研究者

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

Mariagrazia Benedetti

MD Director Physical Medicine and Rehabilitation Unit

Istituto Ortopedico Rizzoli

研究点 (1)

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