NCT01236729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
11 months until next milestone

First Posted

Study publicly available on registry

November 9, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

4 years

First QC Date

December 22, 2009

Last Update Submit

October 17, 2023

Conditions

Keywords

knee replacementdisabilityolder people

Outcome Measures

Primary Outcomes (1)

  • Disability in activities of daily living

    Baseline (recruitment) and at 12 months

Secondary Outcomes (2)

  • Overall self-rated health

    Baseline (recruitment) and at 12 months

  • Health-related quality of life (WOMAC)

    Baseline and 12 months postoperatively

Study Arms (1)

Knee replacement recipients

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

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients refererred to or operated on with primary knee replacement in a population-based tertiary care hospital

You may qualify if:

  • age 75 years or more at the time of operation
  • diagnosis of knee osteoarthritis
  • scheduled for or operated on with primary knee replacement

You may not qualify if:

  • died during the follow-up
  • inflammatory arthritides

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coxa, Hospital for Joint Replacement

Tampere, 33101, Finland

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Esa Jämsen, MD, PhD

    Coxa, Hospital for Joint Replacement

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Researcher

Study Record Dates

First Submitted

December 22, 2009

First Posted

November 9, 2010

Study Start

December 1, 2009

Primary Completion

November 30, 2013

Study Completion

December 31, 2015

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations