Disability and Self-rated Health Following Primary Knee Replacement

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Tampere
Information provided by (Responsible Party):
Esa Jamsen, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier:
NCT01236729
First received: December 22, 2009
Last updated: April 18, 2014
Last verified: April 2014
  Purpose

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
Osteoarthritis
Knee Replacement

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Coxa, Hospital for Joint Replacement:

Primary Outcome Measures:
  • Disability in activities of daily living [ Time Frame: Baseline (recruitment) and at 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall self-rated health [ Time Frame: Baseline (recruitment) and at 12 months ] [ Designated as safety issue: No ]
  • Health-related quality of life (WOMAC) [ Time Frame: Baseline and 12 months postoperatively ] [ Designated as safety issue: No ]
    For patients recruited in 2011-2012.


Enrollment: 460
Study Start Date: December 2009
Estimated Study Completion Date: June 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Knee replacement recipients
Patients (aged 75 years or over) with late-stage arthritis who have undergone or are undergoing primary 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.

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236729

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

Publications:
Responsible Party: Esa Jamsen, MD, PhD, Researcher, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier: NCT01236729     History of Changes
Other Study ID Numbers: KL122009
Study First Received: December 22, 2009
Last Updated: April 18, 2014
Health Authority: Finland: Ethics Committee

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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014