Creating a Tissue Bank of Knee Capsules

Osteoarthritis Clinical Trial

Official title:

Knee Joint Contractures: Reversibility and Molecular Pathways

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01320124
• Other study ID #: 2010930-01H
• Status: Withdrawn
• Phase: N/A
• First received: March 18, 2011
• Last updated: April 22, 2015
• Start date: March 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Contracture
• Knee Joint Contractures
• Osteoarthritis

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of contracture post total knee arthroplasty	1.3% of subjects are expected to develop a contracture post toal knee arthroplasty within a year of the surgery.	Within 1 year	No