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临床试验/NCT00850538
NCT00850538已完成不适用

The Role of Bone and Its Measurement in Knee Osteoarthritis

The New England Baptist Hospital1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2008年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
1
主要终点
Number of Participants With Viable Specimens for Genetic Analysis

研究概览

简要总结

The purpose of the study is to investigate protein and gene expression among damaged knee tissues. We will perform MRI's on subjects prior to total knee replacement to identify the location of bone marrow lesions. Connective tissues including tendon, ligament, and meniscus specimens normally discarded from total joint replacements will be used for live cell harvest, and protein and gene expression analyses of tissue or cultured cells.

详细描述

BACKGROUND AND SIGNIFICANCE:

Although the presence of bone marrow lesions (BML) on MRI is strongly associated with osteoarthritis (OA) progression and pain in some studies, the mechanism for this relation and the underlying pathology is not well established. The lack of knowledge on what these lesions constitute hampers their clinical utility both with regards to measurement and targeting for therapeutic intervention.

Our preliminary data has localized specific changes in bone mineralization, remodeling and defects within BML features that are adjacent to the subchondral plate. BMLs appear to be sclerotic compared to unaffected regions; however, the mineral density in these lesions is reduced and may render this area to be mechanically compromised, and thus susceptible to attrition. Limited histological analysis of BMLs reveal thrombi, diffuse fibrinoid necrosis and hyperplasia of blood vessel walls - all indicative of infarction-like pathology.

The aim of this research proposal is to create more specific targets and improve our understanding of the pathology in BMLs.

Specific Aim 1:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • subjects having primary knee replacement surgery with 1 participating surgeon at NEBH (principal investigator)

排除标准

  • subjects having a revision knee replacement instead of a primary knee replacement
  • contraindications for MRI
  • pregnancy

结局指标

主要结局

Number of Participants With Viable Specimens for Genetic Analysis

时间窗: Tissue samples collected at time of surgery

次要结局

未报告次要终点

研究者

发起方
The New England Baptist Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

David Hunter

PI

The New England Baptist Hospital

研究点 (1)

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