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临床试验/NCT02185365
NCT02185365Unknown不适用

Evaluation of T1rho Magnetic Resonance Imaging for Diagnosis of Cartilage Lesions in Hips With Developmental Dysplasia

Ottawa Hospital Research Institute1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年7月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
Assess proteoglycan amounts in hip cartilage

研究概览

简要总结

One of the leading causes of hip arthritis is developmental dysplasia of the hip (DDH). DDH can lead to major damage in the hip joint and may result in hip arthritis later in life. Patients recruited into this study will be undergoing corrective hip surgery within the next 6 months with a goal of preventing further hip problems down the road. This study is being done to see how well a newer type of Magnetic Resonance Imaging (MRI) detects hip cartilage damage compared to an older but well validated MRI method.

详细描述

The start of arthritis can first be detected in certain molecules in the joint. Proteoglycan is a molecule that is important to cartilage structure, and is lost as arthritis develops. Magnetic resonance imaging (MRI) is one of the best ways to image cartilage, and an investigational MRI technique that has shown great promise in detecting proteoglycan amounts is called T1-rho.

In this study, patients with hip dysplasia will undergo this investigational MRI in addition to a well validated MRI method (called dGEMRIC) to see if T1-rho is as good as dGEMRIC at detecting cartilage damage. The dGEMRIC MRI requires an injection of a contrast agent, while the T1-rho MRI does not. If the T1-rho is shown to be as useful as the dGEMRIC method it can then be used to look at cartilage damage in the hip without having to have an injection.

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
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with a diagnosis of developmental dysplasia of the hip (DDH)

排除标准

  • patients under the age of 18
  • pregnancy and/or lactation
  • non-MRI compatible implants (stents, electronic devices, cardiac pacers or wires)
  • severe claustrophobia
  • prior contrast allergic reaction
  • kidney impairment
  • previous hip surgery
  • osteoarthritis on conventional radiographs (Tönnis Grade>0)
  • additional underlying hip diseases such as posttraumatic arthritis, Legg-Calvé-Perthes-Disease (LCPD), or slipped capital femoral epiphysis (SCFE)

结局指标

主要结局

Assess proteoglycan amounts in hip cartilage

时间窗: Within the 6 months prior to surgery

Our aim is to correlate T1-rho with dGEMRIC values in painful hips with underlying DDH. To achieve this, we will assess whether T1-rho MRI values correlate with dGEMRIC MRI values in hips with DDH.

次要结局

  • Change in iHOT 12 Questionnaire(12 months)
  • Change in WOMAC Questionnaire(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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