OsteoarthritisNCT01236729
Disability and Self-rated Health Following Primary Knee Replacement
An observational study of Osteoarthritis and Knee Replacement, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Osteoarthritis, Knee Replacement
- How many people
- 460 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2009to 31 Dec 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients refererred to or operated on with primary knee replacement in a population-based tertiary care hospital
Who may be able to join
- age 75 years or more at the time of operation
- diagnosis of knee osteoarthritis
- scheduled for or operated on with primary knee replacement
Who cannot join
- died during the follow-up
- inflammatory arthritides
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee Replacement
- Keywords
- knee replacement, disability, older people
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Knee replacement recipients | Patients (aged 75 years or over) with late-stage arthritis who have undergone or are undergoing primary knee replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability in activities of daily living
Measured: Baseline (recruitment) and at 12 months
Secondary outcomes (2)
Overall self-rated health
Measured: Baseline (recruitment) and at 12 months
Health-related quality of life (WOMAC)
For patients recruited in 2011-2012.
Measured: Baseline and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startDec 2009
- Primary completion30 Nov 2013
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coxa, Hospital for Joint Replacement
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Principal investigator, Esa Jamsen, Coxa, Hospital for Joint Replacement
- Investigators
- Esa Jämsen, MD, PhD, Study director, Coxa, Hospital for Joint Replacement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236729
- Sponsor's protocol ID
- KL122009
- Status last verified
- Oct 2023
- First submitted
- 22 Dec 2009
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23147559Vekama 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.
PubMed 25800623
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Primary Knee Replacement for Osteoarthritis on Disability in Activities of Daily Living and Self-rated Health in Older People
- ClinicalTrials.gov ID
- NCT01236729
- Acronym / sponsor ID
- KL122009
- Conditions
- Osteoarthritis, Knee Replacement
- Keywords
- knee replacement, disability, older people
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Coxa, Hospital for Joint ReplacementUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- Dec 2009
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 9 Nov 2010 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee replacement recipients | – | –Patients (aged 75 years or over) with late-stage arthritis who have undergone or are undergoing primary knee replacement |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients refererred to or operated on with primary knee replacement in a population-based tertiary care hospital
Key inclusion criteria (3 listed)
- age 75 years or more at the time of operation
- diagnosis of knee osteoarthritis
- scheduled for or operated on with primary knee replacement
Key exclusion criteria (2 listed)
- died during the follow-up
- inflammatory arthritides
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
Disability in activities of daily living
Time frame: Baseline (recruitment) and at 12 months
2 secondary outcomes
Overall self-rated health
Time frame: Baseline (recruitment) and at 12 months
Health-related quality of life (WOMAC)
Time frame: Baseline and 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Results publication: PubMed 23147559Limnell 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.
- Results publication: PubMed 25800623Vekama 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.
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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.
Esa Jämsen, MD, PhD study director
Coxa, Hospital for Joint Replacement
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 Osteoarthritis and Knee Replacement, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Oct 2023. 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 Finland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disability in activities of daily living (time frame: Baseline (recruitment) and at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236729, which also lists 2 linked publications.
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 18 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.