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临床试验/NCT06451510
NCT06451510招募中不适用

Knee Osteoarthritis in the Region of Norrbotten (KORN)

Umeå University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年9月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Number of participants with radiographic osteoarthritis (OA)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The goal of this observational study is to assess the prevalence of radiographic knee osteoarthritis and to report medium and long term functional outcomes secondary to tibia plateau fractures. The second aim was to investigate whether there were any risk factors associated with these outcomes.

详细描述

  1. The study population consists of patients from the Swedish region of Norrbotten (northern part of Sweden) who had undergone TPF between the years of 2001 and 2015.
  2. All patients are evaluated radiographically.
  3. Condition-specific scores are assessed using the Knee injury and Osteoarthritis Outcome Score (KOOS). General health related quality of life are assessed by the EuroQol 5-Dimension 5-level (EQ-5D-5L) tool.
  4. All patients are examined clinically.
  5. The relationship between the development of radiographic OA in patients who had undergone TPF and such potential factors as gender, age, body mass index (BMI), fracture pattern or method of fracture treatment is being assessed.
  6. The data from the Swedish Fracture Register and the Swedish Arthroplasty Register are used in order to follow the long-term results.

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 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patients from the region of Norrbotten (northern part of Sweden) who underwent tibial plateau fracture between the years of 2001 and 2015

排除标准

  • •Death without bilateral weighted X-ray minimum 5 years post injury
  • •Open growth plate in distal femur and/or proximal tibia
  • •Extraarticular or isolated eminentia fracture
  • •OA prior to injury
  • •Having a rheumatic disorder involving joints
  • •Earlier and/or later severe injury to the index knee
  • •Having cognitive disorders disqualifying from the study

结局指标

主要结局

Number of participants with radiographic osteoarthritis (OA)

时间窗: At least 5 years

Number of participants with radiographic OA at follow-up at least five years after the tibial plateau fracture was considered the primary endpoint of this study.

次要结局

  • Score values in the condition-specific measure for assessment of symptoms and function related to the knee joint(At least 5 years)
  • Score values in assessment of condition-specific health-related quality of life(At least 5 years)
  • Score values in assessment of general health-related qualilty of life(At least 5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Knee Osteoarthritis in the Region of Norrbotten | 临床试验