Knee OsteoarthritisNCT01359553
Clinical Study of Novel Diagnostic Techniques for Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Knee Injuries, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this study is to clarify the potential of intra-articular ultrasound imaging, non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and compared with the arthroscopic findings. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Injuries
- What is being tested?
- Intra-articular ultrasound imaging of knee joint during arthroscopy, Non-invasive ultrasound imaging of knee and Quantitative MRI imaging of knee
- How many people
- 12 participants
- Where
- 1 siteFinland
- Study dates
- May 2011to May 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be selected from those referred to an arthroscopy because of pain symptoms in the knee.
Who may be able to join
- Kellgren-Lawrence grade = 1-3 or cartilage defect detected in MRI
- Age >= 20 years
Who cannot join
- Tumor or inflammation in the knee
- Severe general diseases
- Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Intra-articular Ultrasound Imaging, Non-invasive Ultrasound Imaging, Quantitative MRI Imaging, Contrast-enhanced CT Imaging and Arthroscopy for Diagnostics of Knee Osteoarthritis
The purpose of this study is to clarify the potential of intra-articular ultrasound imaging, non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and compared with the arthroscopic findings.
- Conditions
- Knee Osteoarthritis, Knee Injuries
- Being tested
- Intra-articular ultrasound imaging of knee joint during arthroscopy, Non-invasive ultrasound imaging of knee, Quantitative MRI imaging of knee, Contrast-enhanced CT imaging of knee
- Medical subject headings
- Osteoarthritis, Knee, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular ultrasound imaging of knee joint during arthroscopyOther
Non-invasive ultrasound imaging of kneeOther
Quantitative MRI imaging of kneeOther
Contrast-enhanced CT imaging of kneeOther
| Study group | Role | What they receive |
|---|---|---|
| Knee pain | Group with knee pain problems referred to an arthroscopy. Receives: Other: Intra-articular ultrasound imaging of knee joint during arthroscopy; Other: Non-invasive ultrasound imaging of knee; Other: Quantitative MRI imaging of knee; Other: Contrast-enhanced CT imaging of knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthroscopical OA grade
Measured: 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital, University of Eastern Finland, Kuopio University Hospital
- Responsible party
- Principal investigator, Simo Saarakkala, University of Oulu
- Investigators
- Simo Saarakkala, Ph.D., Principal investigator, University of Oulu and Oulu University HospitalPetri Lehenkari, M.D., Ph.D., Study director, University of Oulu and Oulu University HospitalMiika T Nieminen, Ph.D., Study director, University of Oulu and Oulu University HospitalRisto Ojala, M.D., Ph.D., Study director, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01359553
- Sponsor's protocol ID
- UltraRusto
- Status last verified
- Oct 2016
- First submitted
- 22 May 2011
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intra-articular Ultrasound Imaging, Non-invasive Ultrasound Imaging, Quantitative MRI Imaging, Contrast-enhanced CT Imaging and Arthroscopy for Diagnostics of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01359553
- Acronym / sponsor ID
- UltraRusto
- Conditions
- Knee Osteoarthritis, Knee Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital, University of Eastern Finland, Kuopio University Hospital
- Study start
- May 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 24 May 2011 (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 this study is to clarify the potential of intra-articular ultrasound imaging, non-invasive ultrasound imaging, quantitative MRI imaging, contrast-enhanced CT imaging and arthroscopy for diagnostics of knee osteoarthritis. All methods will be cross-correlated and compared with the arthroscopic findings.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee pain | – | Other: Intra-articular ultrasound imaging of knee joint during arthroscopy, Other: Non-invasive ultrasound imaging of knee, Other: Quantitative MRI imaging of knee, Other: Contrast-enhanced CT imaging of kneeGroup with knee pain problems referred to an arthroscopy. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be selected from those referred to an arthroscopy because of pain symptoms in the knee.
Key inclusion criteria (2 listed)
- Kellgren-Lawrence grade = 1-3 or cartilage defect detected in MRI
- Age >= 20 years
Key exclusion criteria (3 listed)
- Tumor or inflammation in the knee
- Severe general diseases
- Diabetes
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 |
|---|---|---|
| Intra-articular ultrasound imaging of knee joint during arthroscopy | Other | Knee pain |
| Non-invasive ultrasound imaging of knee | Other | Knee pain |
| Quantitative MRI imaging of knee | Other | Knee pain |
| Contrast-enhanced CT imaging of knee | Other | Knee pain |
Primary outcome
Arthroscopical OA grade
Time frame: 2014
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 26 Oct 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.
Simo Saarakkala, Ph.D. principal investigator
University of Oulu and Oulu University Hospital
Petri Lehenkari, M.D., Ph.D. study director
University of Oulu and Oulu University Hospital
Miika T Nieminen, Ph.D. study director
University of Oulu and Oulu University Hospital
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 Knee Osteoarthritis and Knee Injuries, run by University of Oulu 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 2 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 26 Oct 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 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?
Arthroscopical OA grade (time frame: 2014). 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 26 Oct 2016.