Role of Bone in Knee Osteoarthritis (OA)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Sydney

Sydney, New South Wales, 02120, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Radiation

1.5T MRI exam of signal knee with knee coil (estimated time: 35 minutes)

Primary Total Knee Replacement

Procedure

Fluid, bone, and meniscus specimens obtained from total joint replacement will be collected.

Primary outcomes

Number of Participants With Viable Specimens for Genetic Analysis

Time frame: Tissue samples collected at time of surgery

Sponsors and collaborators

Lead sponsor

The New England Baptist Hospital

Other

Registry information

Official study title

The Role of Bone and Its Measurement in Knee Osteoarthritis

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Feb 25, 2009
Registry last updated: Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed