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Disability and Self-rated Health Following Primary Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01236729
Recruitment Status : Active, not recruiting
First Posted : November 9, 2010
Last Update Posted : August 8, 2017
University of Tampere
Information provided by (Responsible Party):
Esa Jamsen, Coxa, Hospital for Joint Replacement

Brief Summary:
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.

Condition or disease
Osteoarthritis Knee Replacement

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
Actual Enrollment : 460 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effects of Primary Knee Replacement for Osteoarthritis on Disability in Activities of Daily Living and Self-rated Health in Older People
Study Start Date : December 2009
Primary Completion Date : June 2013
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Knee replacement recipients
Patients (aged 75 years or over) with late-stage arthritis who have undergone or are undergoing primary knee replacement

Primary Outcome Measures :
  1. Disability in activities of daily living [ Time Frame: Baseline (recruitment) and at 12 months ]

Secondary Outcome Measures :
  1. Overall self-rated health [ Time Frame: Baseline (recruitment) and at 12 months ]
  2. Health-related quality of life (WOMAC) [ Time Frame: Baseline and 12 months postoperatively ]
    For patients recruited in 2011-2012.

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236729

Coxa, Hospital for Joint Replacement
Tampere, Finland, 33101
Sponsors and Collaborators
Coxa, Hospital for Joint Replacement
University of Tampere
Study Director: Esa Jämsen, MD, PhD Coxa, Hospital for Joint Replacement

Responsible Party: Esa Jamsen, MD, PhD, Researcher, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier: NCT01236729     History of Changes
Other Study ID Numbers: KL122009
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Esa Jamsen, Coxa, Hospital for Joint Replacement:
knee replacement
older people

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases