Osteoarthritis, KneeNCT01649518
A Measurement of Knee Osteoarthritis Usual Care
An observational study of Osteoarthritis, Knee and Guideline Adherence, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Osteoarthritis is the most common affection of joints worldwide. Multiple international guidelines on the approach and treatment of knee osteoarthritis are available. Nevertheless there seems to be a gap between usual care and the preferred one. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis, Knee, Guideline Adherence, Quality Indicators, Health Care
- How many people
- 284 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2012to Jul 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General Practice: Based on the electronic patient files of general practiotioners of the MEDIDOC users-group (an electronic software package) a list will be generated of patients diagnosed with knee osteoarthritis. A random sample of these patients will be addressed to take part into the study by a questionnaire. Orthopedic Surgery: Patients, consulting orthopedic surgeons for knee osteoarthritis will receive a patient questionnaire. Physiotherapy: Patients, recruited by general practitioners and orthopedic surgeons will be asked about the care they received by their physiotherapist. Moreover physiotherapists will be recruited by the national association of physiotherapists to complete a questionnaire about the care they usually deliver.
Who may be able to join
- Diagnosis of knee osteoarthritis
Who cannot join
- Knee replacement surgery
- Acute trauma (recruitment by orthopedic surgeons)
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthritis is the most common affection of joints worldwide. Multiple international guidelines on the approach and treatment of knee osteoarthritis are available. Nevertheless there seems to be a gap between usual care and the preferred one.
A vigorous set of evidence-based quality indicators on osteoarthritis diagnosis and therapy was developed by a multidisciplinary expert team. This project aims to map usual care and to explore the gaps between usual care and international guidelines in a second stage. This will enable us to develop a tightly targeted quality improvement intervention later on.
- Medical subject headings
- Osteoarthritis, Knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline adherence measured by a number of quality indicators and presented as the percentage of patients in whom a quality indicator was reached
Guideline adherence by physicians and physiotherapists will be measured by quality indicators. A questionnaire about the care patients received from diagnosis of knee osteoarthritis till now will be used.
Measured: one measurement at the point of recruitment
Secondary outcomes (1)
Barriers and facilitators for guideline adherence
Barriers and facilitators for guideline adherence will be explored by focusgroup research with focusgroups of general practitioners, orthopedic surgeons and patients
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Time perspective
- Retrospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649518
- Sponsor's protocol ID
- S54497
- Status last verified
- Jun 2012
- First submitted
- 18 Jul 2012
- Last updated
- 2 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Measurement of Knee Osteoarthritis Usual Care
- ClinicalTrials.gov ID
- NCT01649518
- Acronym / sponsor ID
- S54497
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2015 (actual)
- First posted
- 25 Jul 2012 (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.
Osteoarthritis is the most common affection of joints worldwide. Multiple international guidelines on the approach and treatment of knee osteoarthritis are available. Nevertheless there seems to be a gap between usual care and the preferred one.
A vigorous set of evidence-based quality indicators on osteoarthritis diagnosis and therapy was developed by a multidisciplinary expert team. This project aims to map usual care and to explore the gaps between usual care and international guidelines in a second stage. This will enable us to develop a tightly targeted quality improvement intervention later on.
Study design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General Practice: Based on the electronic patient files of general practiotioners of the MEDIDOC users-group (an electronic software package) a list will be generated of patients diagnosed with knee osteoarthritis. A random sample of these patients will be addressed to take part into the study by a questionnaire. Orthopedic Surgery: Patients, consulting orthopedic surgeons for knee osteoarthritis will receive a patient questionnaire. Physiotherapy: Patients, recruited by general practitioners and orthopedic surgeons will be asked about the care they received by their physiotherapist. Moreover physiotherapists will be recruited by the national association of physiotherapists to complete a questionnaire about the care they usually deliver.
Key inclusion criteria (1 listed)
- Diagnosis of knee osteoarthritis
Key exclusion criteria (2 listed)
- Knee replacement surgery
- Acute trauma (recruitment by orthopedic surgeons)
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
Guideline adherence measured by a number of quality indicators and presented as the percentage of patients in whom a quality indicator was reached
Time frame: one measurement at the point of recruitment
Guideline adherence by physicians and physiotherapists will be measured by quality indicators. A questionnaire about the care patients received from diagnosis of knee osteoarthritis till now will be used.
1 secondary outcome
Barriers and facilitators for guideline adherence
Time frame: 10 years
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 2 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Knee and Guideline Adherence, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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 2 Jun 2016. 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 Belgium. 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?
Guideline adherence measured by a number of quality indicators and presented as the percentage of patients in whom a quality indicator was reached (time frame: one measurement at the point of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2016.