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Clinical Trials/NCT00850538
NCT00850538
Completed
Not Applicable

The Role of Bone and Its Measurement in Knee Osteoarthritis

The New England Baptist Hospital1 site in 1 country101 target enrollmentJuly 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
The New England Baptist Hospital
Enrollment
101
Locations
1
Primary Endpoint
Number of Participants With Viable Specimens for Genetic Analysis
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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: - To collect tissue to evaluate protein and gene expression of these tissues and cultured cells.

Registry
clinicaltrials.gov
Start Date
July 2008
End Date
April 2013
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
The New England Baptist Hospital
Responsible Party
Principal Investigator
Principal Investigator

David Hunter

PI

The New England Baptist Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Number of Participants With Viable Specimens for Genetic Analysis

Time Frame: Tissue samples collected at time of surgery

Study Sites (1)

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