Creating a Tissue Bank of Knee Capsules

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01320124
Recruitment Status : Withdrawn
First Posted : March 22, 2011
Last Update Posted : April 23, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Guy Trudel, Ottawa Hospital Research Institute

Brief Summary:
A contracture is a pathological condition limiting range and function of joints. Contractures of large and small joints alike will affect one's ability to independently perform daily activities such as eating, dressing or walking. Current treatments for contractures include physical stretching, the use of assistive devices or, rarely, surgery. Despite prolonged treatments, patients with contractures rarely regain complete mobility. Progress in preventing and treating contractures will be possible only through an understanding of the biological and molecular processes involved. Our group has established and validated an animal model to study the histological events and the molecular mechanisms involved in joint contractures. We have provided evidence for capsule stiffness, characterized cartilage degeneration, and identified four genes whose expression is altered in the cartilage of a knee joint with contracture. The work we propose in the current study aims at finding genes and pathways in the joint capsule associated with knee joint contractures. The results will identify new avenues for treating the large number of patients suffering from contractures.

Condition or disease
Osteoarthritis Knee Joint Contractures

Detailed Description:

We propose to constitute a bank of capsule samples from people with osteoarthritis undergoing primary total knee arthroplasty. It is expected that about 1.3% of people will develop a contracture post arthroplasty. A second sample will be taken from those that require surgery for release of contracture or revision. We will study histological characteristics and compare gene expression between the primary sample and the contracture sample in the same patient. In order to determine whether intrinsic genetic factors influence the develpment of joint contractures in the osteoarthritis population, all specimens will be analyzed for differential gene expression between patients with and without knee contractures post arthroplasty.

The remaining capsule tissue not used for this study will be banked and made available to other researchers.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Knee Joint Contractures: Reversibility and Molecular Pathways
Study Start Date : March 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

osteoarthritis, total knee arthroplasty
The main cohort will have a total knee arthroplasty and will not develop a contracture post surgery. We will analyze differntial gene expression in all subjects.
contracture post arthroplasty
A small group (1.3%) will develop a contracture post total knee arthroplasty. A second sample will be taken at the time of corrective surgery. The 2 samples will be compared for gene expression in the same subject. This group will also be compared to the main cohort for differential gene expression.

Primary Outcome Measures :
  1. development of contracture post total knee arthroplasty [ Time Frame: Within 1 year ]
    1.3% of subjects are expected to develop a contracture post toal knee arthroplasty within a year of the surgery.

Biospecimen Retention:   Samples With DNA
A blood sample will be drawn from each subject and stored with the capsule tissue.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients booked for a total knee arthroplasty at the Ottawa Hospital, with a primary diagnosis of osteoarthritis.

Inclusion Criteria:

  • Osteoarthritis, booked for a total knee arthroplasty

Exclusion Criteria:

  • Transmissible disease (e.g., HIV infection, hepatitis B or C)
  • Suspected neoplasia
  • Suspected infection (which can cause arthrofibrosis)
  • Hypertrophic scarring

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 identifier (NCT number): NCT01320124

Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8M2
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Guy Trudel, MD University of Ottawa

Responsible Party: Dr. Guy Trudel, Researcher, Ottawa Hospital Research Institute Identifier: NCT01320124     History of Changes
Other Study ID Numbers: 2010930-01H
First Posted: March 22, 2011    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015

Keywords provided by Dr. Guy Trudel, Ottawa Hospital Research Institute:
Total knee arthroplasty
Tissue bank
Gene expressions

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Muscular Diseases