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Role of Bone in Knee Osteoarthritis (OA)

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ClinicalTrials.gov Identifier: NCT00850538
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : December 4, 2015
Last Update Posted : December 4, 2015
Sponsor:
Information provided by (Responsible Party):
David Hunter, The New England Baptist Hospital

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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Radiation: MRI Procedure: Primary Total Knee Replacement

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.


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Study Type : Observational
Actual Enrollment : 101 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Bone and Its Measurement in Knee Osteoarthritis
Study Start Date : July 2008
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis


Intervention Details:
  • Radiation: MRI
    1.5T MRI exam of signal knee with knee coil (estimated time: 35 minutes)
  • Procedure: Primary Total Knee Replacement
    Fluid, bone, and meniscus specimens obtained from total joint replacement will be collected.


Primary Outcome Measures :
  1. Number of Participants With Viable Specimens for Genetic Analysis [ Time Frame: Tissue samples collected at time of surgery ]

Biospecimen Retention:   Samples Without DNA
Tibial plateau patella fat pad synovial fluid and synovium


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Male or female, over age 18, with scheduled primary total knee replacement surgery at NEBH, with no contradindications for MRI
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850538


Locations
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Australia, New South Wales
University of Sydney
Sydney, New South Wales, Australia, 02120
Sponsors and Collaborators
The New England Baptist Hospital
Investigators
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Principal Investigator: David Hunter, MD University of Sydney

Additional Information:
Publications:

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Responsible Party: David Hunter, PI, The New England Baptist Hospital
ClinicalTrials.gov Identifier: NCT00850538     History of Changes
Other Study ID Numbers: NEBH 2008-018
First Posted: February 25, 2009    Key Record Dates
Results First Posted: December 4, 2015
Last Update Posted: December 4, 2015
Last Verified: November 2015
Keywords provided by David Hunter, The New England Baptist Hospital:
Bone Marrow Lesion
BML
Arthroplasty
Replacement
Knee
Discarded tissue
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases