- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01236729
Disability and Self-rated Health Following Primary Knee Replacement
October 17, 2023 updated by: Esa Jamsen, Coxa, Hospital for Joint Replacement
The Effects of Primary Knee Replacement for Osteoarthritis on Disability in Activities of Daily Living and Self-rated Health in Older People
Knee replacement is an effective treatment in late-stage osteoarthritis.
It reduces pain and improves quality of life.
There is, however, limited data concerning its results in older people and on its effect on how patients survive in regular activities of daily living (ADL), such as bathing and shopping.
In this study, the results of knee replacement are evaluated from the point of view of disability in everyday activities and self-rated health.
Moreover, association with ADL performance and clinical knee scores and severity of osteoarthritis are assessed.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a cross-sectional study with a 12 month follow-up for recruited patients.
Most data are gathered by a postal questionnaire.
Study Type
Observational
Enrollment (Actual)
460
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tampere, Finland, 33101
- Coxa, Hospital for Joint Replacement
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients refererred to or operated on with primary knee replacement in a population-based tertiary care hospital
Description
Inclusion Criteria:
- age 75 years or more at the time of operation
- diagnosis of knee osteoarthritis
- scheduled for or operated on with primary knee replacement
Exclusion Criteria:
- died during the follow-up
- inflammatory arthritides
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Knee replacement recipients
Patients (aged 75 years or over) with late-stage arthritis who have undergone or are undergoing primary knee replacement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Disability in activities of daily living
Time Frame: Baseline (recruitment) and at 12 months
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Baseline (recruitment) and at 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall self-rated health
Time Frame: Baseline (recruitment) and at 12 months
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Baseline (recruitment) and at 12 months
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Health-related quality of life (WOMAC)
Time Frame: Baseline and 12 months postoperatively
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For patients recruited in 2011-2012.
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Baseline and 12 months postoperatively
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Esa Jämsen, MD, PhD, Coxa, Hospital for Joint Replacement
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Limnell K, Jamsen E, Huhtala H, Jantti P, Puolakka T, Jylha M. Functional ability, mobility, and pain before and after knee replacement in patients aged 75 and older: a cross-sectional study. Aging Clin Exp Res. 2012 Dec;24(6):699-706. doi: 10.3275/8718. Epub 2012 Nov 12.
- Vekama L, Puolakka T, Honkasalo M, Huhtala H, Moilanen T, Jamsen E. Functional gain following knee replacement in patients aged 75 and older: a prospective follow-up study. Aging Clin Exp Res. 2015 Dec;27(6):865-76. doi: 10.1007/s40520-015-0348-x. Epub 2015 Mar 24.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
November 30, 2013
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
December 22, 2009
First Submitted That Met QC Criteria
November 8, 2010
First Posted (Estimated)
November 9, 2010
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KL122009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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