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临床试验/NCT03445481
NCT03445481终止不适用

Pilot Study of New Prosthesis for Trans-femoral Amputated Patients Clinical Study Protocol

Christian Candrian1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2018年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Quality of Life

研究概览

简要总结

Patients with a trans-femoral amputation who experienced problems, complications pain due to the ischial weight bearing and discomfort with conventional socket prosthesis will be proposed to implant a new developed prosthesis.

详细描述

The patients will undergo a surgical operation to implant a femoral prosthesis according to the hospital's protocol. The surgical intervention will be performed under general or spinal anesthesia with a tourniquet at the root of the lower limb. Under sterile conditions, the incision of the stump will be done at the level of the previous surgical scar. Preserving the soft tissue, the distal femoral bone is reached. Then, the medullary canal is opened and prepared with reamers of increasing diameter. A femoral cemented stem of appropriate dimensions correlated to the size of the canal and 105 mm of height is implanted. To the above-mentioned stem, the Medacta prosthesis will be fixed with a blocking screw. The prosthesis is then covered with the soft tissue and layered suturing of the stump is performed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18 and <75 years
  • Patients with Trans-femoral Amputations since at least 2 years and suffering from pain and discomfort with the current standard socket prosthesis, i.e., with a baseline VAS score for pain between 3 and 10 or a health-related quality of life (Eq-5D) score < 60 or an SF-36 result below the 50th percentile
  • Amputation due to:
  • Oncologic disease
  • Written informed consent

排除标准

  • Trans-femoral amputation due to infection
  • Patients affected by
  • metabolic disease
  • neurologic degenerative disease
  • vascular disease proximal to the amputation
  • body weight >100 kg
  • Hip arthritis of the amputated limb

研究组 & 干预措施

Femoral prosthesis

Experimental

newly developed prosthesis for trans-femoral amputation

干预措施: Medacta femoral prosthesis (Device)

结局指标

主要结局

Quality of Life

时间窗: Two years

Patients outcome evaluation of health-related quality of life through quality of life questionnaire EQ-5D-5L

次要结局

  • Adverse Events(Two years)

研究者

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

Christian Candrian

MD

Ente Ospedaliero Cantonale, Bellinzona

研究点 (1)

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