Joint ContractureNCT00664651
Joint Stiffness Following Knee Replacement Surgery
An observational study of Joint Contracture, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Our primary research question is to find out whether there is a genetic component to the development of joint contractures following knee surgery, through the application of lab techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Contracture
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2006to 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: joint contractures following knee surgery
Who may be able to join
- -knee contractures post arthroplasty scheduled for arthrotomy with debridement of capsular tissue Controls will be patients scheduled for arthrotomy with debridement of capsular tissue for the other reasons(primary knee arthroplasty, ORIF of the knee secondary to trauma, ACL repair, amputation, elective joint arthroplasty with capsuloplasty etc.)
Who cannot join
- transmissible disease (HIV, Hep B,C)
- confirmed or suspected neoplasia
- suspected infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capsular Changes in Joint Contractures Post-Knee Arthroplasty:A Case-Control Study
Our primary research question is to find out whether there is a genetic component to the development of joint contractures following knee surgery, through the application of lab techniques.
Read the detailed description
After total knee replacement surgery, some people develop joint stiffness, which is also called a joint contracture. Contractures cause the envelope of the knee (called the capsule) to stiffen and become rigid so the patient can no longer move their knee the way they used to. After stretching and other exercises, only a surgery can try and divide or remove the contracture. The main purpose of this research is to study the cause of the contracture and specifically if certain people are predisposed to contractures.
- Conditions
- Joint Contracture
- Keywords
- joint contracture, total knee arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression
Measured: Dec 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startDec 2006
- 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 Joint ContractureStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Guy Trudel, Ottawa Hospital Research Institute
- Investigators
- Guy Trudel, MD,MSc,FRCPC, Principal investigator, OHRI / The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664651
- Sponsor's protocol ID
- 2006541
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2008
- 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
- Capsular Changes in Joint Contractures Post-Knee Arthroplasty:A Case-Control Study
- ClinicalTrials.gov ID
- NCT00664651
- Acronym / sponsor ID
- 2006541
- Conditions
- Joint Contracture
- Keywords
- joint contracture, total knee arthroplasty
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Dec 2006
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Apr 2008 (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.
Our primary research question is to find out whether there is a genetic component to the development of joint contractures following knee surgery, through the application of lab techniques.
Detailed description
After total knee replacement surgery, some people develop joint stiffness, which is also called a joint contracture. Contractures cause the envelope of the knee (called the capsule) to stiffen and become rigid so the patient can no longer move their knee the way they used to. After stretching and other exercises, only a surgery can try and divide or remove the contracture. The main purpose of this research is to study the cause of the contracture and specifically if certain people are predisposed to contractures.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- joint contractures following knee surgery
Key inclusion criteria (1 listed)
- -knee contractures post arthroplasty scheduled for arthrotomy with debridement of capsular tissue Controls will be patients scheduled for arthrotomy with debridement of capsular tissue for the other reasons(primary knee arthroplasty, ORIF of the knee secondary to trauma, ACL repair, amputation, elective joint arthroplasty with capsuloplasty etc.)
Key exclusion criteria (3 listed)
- transmissible disease (HIV, Hep B,C)
- confirmed or suspected neoplasia
- suspected infection
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
Gene expression
Time frame: Dec 2015
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,MSc,FRCPC principal investigator
OHRI / The Ottawa Hospital
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 Joint Contracture, 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 3 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?
Gene expression (time frame: Dec 2015). 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.