OsteoarthritisNCT01320124
Creating a Tissue Bank of Knee Capsules
An observational study of Osteoarthritis and Knee Joint Contractures, run by Ottawa Hospital Research Institute at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee Joint Contractures
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2011to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients booked for a total knee arthroplasty at the Ottawa Hospital, with a primary diagnosis of osteoarthritis.
Who may be able to join
- Osteoarthritis, booked for a total knee arthroplasty
Who cannot join
- Transmissible disease (e.g., HIV infection, hepatitis B or C)
- Suspected neoplasia
- Suspected infection (which can cause arthrofibrosis)
- Hypertrophic scarring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knee Joint Contractures: Reversibility and Molecular Pathways
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee Joint Contractures
- Keywords
- Contractures, Total knee arthroplasty, Tissue bank, Osteoarthritis, Gene expressions
- Medical subject headings
- Osteoarthritis, Contracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Guy Trudel, Ottawa Hospital Research Institute
- Investigators
- Guy Trudel, MD, Principal investigator, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320124
- Sponsor's protocol ID
- 2010930-01H
- Status last verified
- Apr 2015
- First submitted
- 18 Mar 2011
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Joint Contractures: Reversibility and Molecular Pathways
- ClinicalTrials.gov ID
- NCT01320124
- Acronym / sponsor ID
- 2010930-01H
- Conditions
- Osteoarthritis, Knee Joint Contractures
- Keywords
- Contractures, Total knee arthroplasty, Tissue bank, Osteoarthritis, Gene expressions
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients booked for a total knee arthroplasty at the Ottawa Hospital, with a primary diagnosis of osteoarthritis.
Key inclusion criteria (1 listed)
- Osteoarthritis, booked for a total knee arthroplasty
Key exclusion criteria (4 listed)
- Transmissible disease (e.g., HIV infection, hepatitis B or C)
- Suspected neoplasia
- Suspected infection (which can cause arthrofibrosis)
- Hypertrophic scarring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Trudel, MD principal investigator
University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Knee Joint Contractures, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of contracture post total knee arthroplasty (time frame: Within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2015.