跳至主要内容
临床试验/NCT03885960
NCT03885960进行中(未招募)不适用

A Prospective Nationwide Study of Perthes' Disease in Norway: Functional and Radiographic Outcomes at a Mean Follow-up of Twenty Years

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
216
试验地点
1
主要终点
Hip osteoarthritis

研究概览

简要总结

Calvé-Legg-Perthes disease (CLP) is a hip disease in children whose femoral head becomes completely or partially necrotic. The disease is most common in five-six years of age. The femoral head is gradually deformed during the active stages of the disease (5-7 years). By healing, the hip joint shape will vary from an approximately normal joint to pronounced changes, the hip joint will be irregular. Such a hip joint is available for osteoarthritis. The purpose of this study is to map the function of the hip, the patient's quality of life and especially the risk factors that affect the outcome of the previous CLP. A nationwide prospective study of CLP was conducted between 1996 and 2000. All children with newly diagnosed Perthes disease (425) were registered. The current study will follow up all these patients with an average follow-up of 20 years. Radiological endpoints are evidence of hip osteoarthritis. Patient-reported outcomes (PROMS) should illuminate the function of the hip and quality of life.

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
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Death upon follow up
  • Other skeletal dysplasia
  • Patient not able to give consent,

结局指标

主要结局

Hip osteoarthritis

时间窗: an average of 20 years follow-up

radiographic measurement of weight bearing zone

Hip function

时间窗: an average of 20 years follow-up

PROMS HOOS

次要结局

  • Hip ROM(an average of 20 years follow-up)
  • Gluteal muscle strength(an average of 20 years follow-up)
  • Hip strength(an average of 20 years follow-up)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefan Huhnstock

Principal investigator

Oslo University Hospital

研究点 (1)

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