Osteoarthritis, KneeNCT02673801
Optimized Referral of Knee Patients to the Orthopedic Outpatient Clinic
An observational study of Osteoarthritis, Knee, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
The purpose of the study is to evaluate an algorithm to screen patients with suspected knee osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and patient-reported symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Orthopedic assessment in the outpatient clinic
- How many people
- 226 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2015to Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis
Who may be able to join
- All patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis.
Who cannot join
- Cognitive or language problems that precludes the filling in of the questionnaires
- Unwillingness to answer the questionnaires
- Patients with rheumatoid arthritis, neurological diseases or cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OPtimeret Kirurgisk Visitation af Knæartrose Patienter (OPKVIK)
The purpose of the study is to evaluate an algorithm to screen patients with suspected knee osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and patient-reported symptoms. It will be investigated whether the algorithm is able to identify which patients that are deemed relevant to undergo an orthopedic assessment. This will be evaluated by estimating the sensitivity of the new algorithm compared to with the traditional clinical assessment of the patients.
Read the detailed description
Further description is provided as eligibility criteria and outcome measures.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Orthopedic assessment in the outpatient clinic
- Keywords
- Referral and Consultation, Orthopedics
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthopedic assessment in the outpatient clinicOther
Orthopedic assessment based on clinic evaluation, patient symptoms and radiographic evaluation
| Study group | Role | What they receive |
|---|---|---|
| Patient referred to orthopedic clinic | Orthopedic assessment in the outpatient clinic as well as a new algorithm (using patient-reported symptoms and radiographic evaluation) will be applied Receives: Other: Orthopedic assessment in the outpatient clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
"Relevant" or "Not relevant" for orthopedic assessment
Results from the algorithm as well as radiographs and the clinic examination
Measured: Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
Secondary outcomes (1)
Knee Injury an Osteoarhtritis Outcome Score (KOOS)
Patient reported symptoms, stiffness, pain, activities of daily living (ADL), function in sport and recreation and knee related quality of life
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startAug 2015
- Primary completionOct 2015
- Study completionOct 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.
- 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
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lone R Mikkelsen, PhD, Principal investigator, Research physiotherapist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673801
- Sponsor's protocol ID
- 63 00001
- Status last verified
- Aug 2015
- First submitted
- 22 Jan 2016
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data can be provided upon request, for instance for meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimeret Kirurgisk Visitation af Knæartrose Patienter (OPKVIK)
- ClinicalTrials.gov ID
- NCT02673801
- Acronym / sponsor ID
- 63 00001
- Conditions
- Osteoarthritis, Knee
- Keywords
- Referral and Consultation, Orthopedics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 4 Feb 2016 (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.
The purpose of the study is to evaluate an algorithm to screen patients with suspected knee osteoarthritis referred to an orthopedic outpatient clinic by using radiographs and patient-reported symptoms. It will be investigated whether the algorithm is able to identify which patients that are deemed relevant to undergo an orthopedic assessment. This will be evaluated by estimating the sensitivity of the new algorithm compared to with the traditional clinical assessment of the patients.
Detailed description
Further description is provided as eligibility criteria and outcome measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient referred to orthopedic clinic | – | Other: Orthopedic assessment in the outpatient clinicOrthopedic assessment in the outpatient clinic as well as a new algorithm (using patient-reported symptoms and radiographic evaluation) will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis
Key inclusion criteria (1 listed)
- All patients with a new referral to the orthopedic outpatient clinic with suspected knee osteoarthritis.
Key exclusion criteria (3 listed)
- Cognitive or language problems that precludes the filling in of the questionnaires
- Unwillingness to answer the questionnaires
- Patients with rheumatoid arthritis, neurological diseases or cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthopedic assessment in the outpatient clinicOrthopedic assessment based on clinic evaluation, patient symptoms and radiographic evaluation | Other | Patient referred to orthopedic clinic |
Primary outcome
"Relevant" or "Not relevant" for orthopedic assessment
Time frame: Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)
Results from the algorithm as well as radiographs and the clinic examination
1 secondary outcome
Knee Injury an Osteoarhtritis Outcome Score (KOOS)
Time frame: At baseline
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 4 Feb 2016.
- Individual participant dataSharing planned: No. Data can be provided upon request, for instance for meta-analysis.
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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.
Lone R Mikkelsen, PhD principal investigator
Research physiotherapist
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, run by Central Jutland Regional Hospital at 1 site in Denmark.
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 3 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 4 Feb 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 Denmark. 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?
"Relevant" or "Not relevant" for orthopedic assessment (time frame: Through study completion, an average of 1 day (at the initial visit in the orthopedic outpatient clinic)). 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 4 Feb 2016.