Creating a Tissue Bank of Knee Capsules

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01320124
First received: March 18, 2011
Last updated: May 11, 2011
Last verified: May 2011
  Purpose

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
Osteoarthritis
Knee Joint Contractures

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Knee Joint Contractures: Reversibility and Molecular Pathways

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • development of contracture post total knee arthroplasty [ Time Frame: Within 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1500
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01320124

Contacts
Contact: Elizabeth Coletta, RN (613)737-7350 ext 75691 ecoletta@ottawahospital.on.ca
Contact: Guy Trudel, MD (613)737-7350 ext 75591 gtrudel@ottawahospital.on.ca

Locations
Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8M2
Principal Investigator: Odette Laneuville, PhD         
Principal Investigator: Guy Trudel, MD         
Sub-Investigator: Hans K Uhthoff, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Guy Trudel, MD University of Ottawa
  More Information

No publications provided

Responsible Party: Dr. Guy Trudel, University of Ottawa
ClinicalTrials.gov Identifier: NCT01320124     History of Changes
Other Study ID Numbers: 2010930-01H
Study First Received: March 18, 2011
Last Updated: May 11, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Contractures
Total knee arthroplasty
Tissue bank
Osteoarthritis
Gene expressions

Additional relevant MeSH terms:
Contracture
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014