跳至主要内容
临床试验/NCT00504114
NCT00504114已完成不适用

MR Imaging of Knee Osteoarthritis and Acute Knee Injuries

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2006年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
139
试验地点
1
主要终点
Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes

研究概览

简要总结

The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to examine the knee and the bony and soft tissue changes so as to better predict the progression of osteoarthritis and acute knee injuries.

详细描述

The study will examine the pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes; and evaluate T1p relaxation methods and its' relating to cartilage loss. The protocol is geared towards sequences utilizing 3 Tesla magnetic resonance imaging (MRI) that will enable the measures of cartilage volume and T2. Measures cartilage volume and T2 are more established MR methods for studying osteoarthritis (OA).

All OA and Anterior cruciate ligament (ACL) subjects will undergo MR imaging of the knee joint at 3 Tesla at baseline,, and three annual follow up time points. Regions of interest will include the total tibial and femoral cartilage, and sub-division such as the medial and lateral compartments of the tibial and femoral cartilage to account for localized disease activity and progression.

Bone marrow edema size, MR spectroscopy based marrow fat/water content, and trabecular bone microarchitecture underlying the edema will be measured in the OA and ACL groups to determine whether there is any distinction between these measures in OA and in traumatic ACL injury, cross-sectionally and longitudinally, and their relation to cartilage loss and OA progression.

研究设计

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

入排标准

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

入选标准

  • Healthy volunteers will have had no previous knee symptoms or surgery
  • Patients with mild arthritic symptoms and Kellgren Lawrence score of 2
  • Patients with severe arthritic symptoms and Kellgren Lawrence score of 3, or 4
  • Patients with acute ACL injury with associated bone contusion and bone edema
  • Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures
  • Patient is willing to participate in the proposed study as evidenced by providing written informed consent.

排除标准

  • Current use of an investigational drug
  • Conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy or a stroke.)
  • Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI

结局指标

主要结局

Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes

时间窗: Baseline, 1 year, 2 year, 3 year

次要结局

  • Evaluate T1rho relaxation methods and its' relation to cartilage loss(Baseline, 1 year, 2 year, 3 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

MR Imaging of Knee Osteoarthritis and Acute Knee... | 临床试验