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临床试验/NCT04402502
NCT04402502已完成不适用

Dynamic 4DCT to Examine the Effect of Mal-united Distal Radius Fractures on Carpal Contact Mechanics

Western University, Canada1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2018年9月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
57
试验地点
1
主要终点
Hand Joint Spacing

研究概览

简要总结

Osteoarthritis can develop after an injury like a broken bone. Problems with how the bones line up can lead to abnormal loading which will destroy the cartilage that covers and protects the bones. Once this happens, patients experience substantial pain and disability. Researchers and doctors use planar x-rays to evaluate joints; but these are not always precise and are limited to two dimensions. Three-dimensional (3D) computed tomography (CT) can be used to look at the joints of the wrist in three dimensions, but is limited to static frames. Symptoms arising from joint instability often occur when the wrist is moving and when it is performing a functional task (opening a jar). Four dimensional computed tomography (4DCT) can detect dynamics changes in the small structures of the wrist with high temporal and spatial resolution. This novel imaging techniques provides a movie of bones in the wrist, in 3D, while in the scanner. In this proposal, the investigator's will use 4DCT and look at how joint alignment of the distal radius effects the joints in the wrist, and investigate how it relates to patient's function, description of pain and the presence of Osteoarthritis 10 years following fracture. This imaging will drive safer clinical research and practice and will develop tools that predict the risk of developing arthritis that will help doctors determine when surgery is necessary to prevent arthritis of the hand and wrist, and pain and disability.

详细描述

A series of 60 participants (30 male: 30 female) with current distal radius fractures will be recruited. Clinical eligibility will include a unilateral DRF treated with closed reduction and casting. These measures will be assessed at baseline (<6 weeks following injury), 3- 6 months and 12 months following fracture. A second series of 80 participants (40 male: 40 female) who suffered a DRF ≥10 years previously will be recruited and tested. Exclusion criteria for these two cohorts will include presence of neurological disorders, rheumatoid arthritis or co-morbid health conditions that preclude completion of study measures. Twenty additional healthy participants will be recruited.

研究设计

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

入排标准

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

入选标准

  • •fluent in English, capacity to provide consent,
  • •over the age of 18 years old, with no previous injury to either hand or wrist

排除标准

  • •pregnancy and presence of neurological disorders, rheumatoid arthritis or comorbid health conditions that preclude completion of study measures

研究组 & 干预措施

Healthy Population

Experimental

Healthy Individuals with no presence of neurological disorders, rheumatoid arthritis or comorbid health conditions, and are not pregnant.

干预措施: Ultrasound Imaging (Device)

结局指标

主要结局

Hand Joint Spacing

时间窗: 3 years

To measure joint spacing of the hand in a 3D ultrasound image

次要结局

未报告次要终点

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (1)

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