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临床试验/NCT02098044
NCT02098044Unknown不适用

An Investigation of the Prevalence of Knee Osteoarthritis and Pain in Retired Professional Male Footballers in the United Kingdom

University of Nottingham1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,300
试验地点
1
主要终点
Self Reported Knee Pain

研究概览

简要总结

The OA and Football Study is an epidemiological study designed to establish the prevalence of knee osteoarthritis in retired professional footballers. The study will also identify the key risk factors associated with knee osteoarthritis. The study is comprised of three phases: Phase I involves the dissemination of a questionnaire (demographic details, players history, injury and surgery and other known risk factors of OA), Phase II is a radiographic study that involves x-rays in a sample of footballers both with and without knee pain and Phase III is a case control study which will compared retired professional footballers with age-matched controls recruited from the general population in the East Midlands region.

详细描述

Number of Participants:

Phase I: 1000 Phase II: 855 Phase III: 500

Primary outcome: The questionnaire will contain player specific information and will include validated outcome measures such as the health status questionnaire as well as self-reported pain, recall of injury and surgery history. The results of the questionnaire will be exported firstly to Excel and subsequently, into MS Access as part of a managed database.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • All current or retired professional male footballers (Registered with the Professional Footballer Association (age range 40 -80)
  • Inclusion Criteria:
  • Professional footballers both with and without a history of knee pain knee OA or knee surgical history
  • No contraindications of the affected joint such as gout or rheumatoid arthritis
  • Willingness to participate in a clinical assessment of the knee and provision of blood samples.
  • Inclusion Criteria for controls:
  • Over the age of 40 (age range 40 - 80)
  • Both with and without a history of knee pain over at least the last 1 year
  • No history of significant trauma, injury or surgery to the lower limb
  • American College of Rheumatology (ACR) classification of OA based on physical examination and clinical presentation: Pain in the knee and three of the following; over the age of 50, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement and no palpable warmth of synovium.

排除标准

  • Not a registered professional footballer (current or past)
  • Inaccurate information (discrepancy with questionnaire information compared to other football records. This will be verified by the co-investigator, Dr Fernandes and Mr Sanjay Parekh)
  • Incomplete questionnaire or duplicate questionnaire.
  • Exclusion Criteria:
  • Not a registered professional footballer
  • No written informed consent to participate
  • Exclusion Criteria:
  • Aged 39 and under
  • Comorbidities such as rheumatoid arthritis, gout, osteoporosis
  • History of injury, trauma or surgery to the lower limb.

结局指标

主要结局

Self Reported Knee Pain

时间窗: up to 12 months

Questionnaire data with regards to acute knee pain, type of pain, duration of pain and knee injury and knee surgery history.

次要结局

  • Radiographic Knee OA changes(up to 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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