OsteoarthritisMAKneeNCT02937064
Multimodal Assessment of Knee Conditions
An observational study of Osteoarthritis and Injury of Anterior Cruciate Ligament, run by University of Oulu at 1 site in Finland.
Trial summary
The purpose of this study is to assess both osteoarthritis and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint. Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Injury of Anterior Cruciate Ligament, Knee Injuries and Disorders
- How many people
- 109 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2016to Mar 2017
- 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 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Controls will be recruited using the newspaper advertisement. Subject with anterior cruciate ligament injuries will be recruited from the orthopaedic department and osteoarthritic subjects using patient Records of Oulu University Hospital.
Who may be able to join
- Age 45 - 65
Who cannot join
- Rheumatoid arthritis
- Weight over 110 kg
- Previous total knee replacement surgery
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess both osteoarthritis and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.
- Medical subject headings
- Osteoarthritis, Anterior Cruciate Ligament Injuries, Knee Injuries, Disease
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 |
|---|---|---|
| Controls | Controls | |
| ACL subjects | Subjects with anterior cruciate ligament injuries. | |
| OA1, doubtful OA | Subjects with doubtful osteoarthritis. | |
| OA2, mild OA | Subjects with mild osteoarthritis. | |
| OA3, moderate OA | Subjects with moderate osteoarthritis. | |
| OA4, severe OA | Subjects with severe osteoarthritis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of osteoarthritis (confirmed using X-ray and magnetic resonance imaging)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Oulu University Hospital
- Responsible party
- Sponsor
- Investigators
- Simo Saarakkala, Ph.D., Principal investigator, University of OuluOsmo Tervonen, M.D., Ph.D., Study director, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937064
- Sponsor's protocol ID
- 24302214
- Acronym
- MAKnee
- Status last verified
- May 2017
- First submitted
- 12 Oct 2016
- Last updated
- 4 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Knee Conditions
- ClinicalTrials.gov ID
- NCT02937064
- Acronym / sponsor ID
- MAKnee / 24302214
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Oulu University Hospital
- Study start
- Nov 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 18 Oct 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 this study is to assess both osteoarthritis and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Controls |
| ACL subjects | – | –Subjects with anterior cruciate ligament injuries. |
| OA1, doubtful OA | – | –Subjects with doubtful osteoarthritis. |
| OA2, mild OA | – | –Subjects with mild osteoarthritis. |
| OA3, moderate OA | – | –Subjects with moderate osteoarthritis. |
| OA4, severe OA | – | –Subjects with severe osteoarthritis. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Controls will be recruited using the newspaper advertisement. Subject with anterior cruciate ligament injuries will be recruited from the orthopaedic department and osteoarthritic subjects using patient Records of Oulu University Hospital.
Key inclusion criteria (1 listed)
- Age 45 - 65
Key exclusion criteria (4 listed)
- Rheumatoid arthritis
- Weight over 110 kg
- Previous total knee replacement surgery
- Contraindications to MRI
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
Severity of osteoarthritis (confirmed using X-ray and magnetic resonance imaging)
Time frame: 6 months
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 May 2017.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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
Osmo Tervonen, M.D., Ph.D. study director
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 Osteoarthritis and Injury of Anterior Cruciate Ligament, 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 1 inclusion and 4 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 May 2017. 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?
Severity of osteoarthritis (confirmed using X-ray and magnetic resonance imaging) (time frame: 6 months). 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 May 2017.