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临床试验/NCT04422717
NCT04422717已完成不适用

Ultrasonographic Evaluation of Femoral Cartilage Thickness In Patients With Lower Limb Amputation

Istanbul Physical Medicine Rehabilitation Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Ultrasonographic Evaluation of Femoral Cartilage Thickness

研究概览

简要总结

The aim of the study to investigate any relation with functional parameters and femoral cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals.

详细描述

In this prospective observational study, subjects approached Tertiary Rehabilitation Clinics for prothesis recipe or long term outpatient follow up was 150 people. Among them 76 subjects accepted to enroll study. Informed consent was taken. Subjects firstly performed clinical parameters at the first doctor's control. Knee radiography has been performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being a single lower limb amputation
  • At least one year after the amputation operation
  • Prosthesis use for the last 6 months
  • Being traumatic or vascular
  • Not having stump infection
  • Muscle strength over stump should be at least 3/5

排除标准

  • Doing quadriceps exercise in the last 3 months
  • Trauma, surgery, and knee injections within 6 months (PRP, hyaluronic acid), Chondroitin-glucosamine use.
  • Being any of the active synovitides, Rheumatoid arthritis, spondyloarthritis, pseudogout, coxarthrosis, neuromuscular diseases
  • Having an additional disease that will cause psychiatric adjustment problem
  • Subjects are younger than 18 years
  • Bilateral amputated

结局指标

主要结局

Ultrasonographic Evaluation of Femoral Cartilage Thickness

时间窗: Day 1

The transtibial amputee's both knees femoral cartilage are measured. The transfemoral group is measured only femoral cartilage of intact side. 10 subjects are randomised for intraobserver reliability and reevaluated one month after their first measure.

次要结局

  • Trinity Amputation and Prosthesis Experience Scale (TAPES)(Day 1)
  • Houghton Scale(Day 1)
  • Short Form - 12 (SF-12)(Day 1)
  • Medicare Functional Classification Levels (K levels)(Day 1)
  • Falls Efficacy Scale(Day 1)
  • Locomotor Capabilities Index (LCI) -5(Day 1)

研究者

发起方
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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