OsteoarthritisNCT00665548
Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA)
An observational study of Osteoarthritis, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of the study is to use different x-ray and magnetic resonance (MR) imaging techniques to take pictures of the knee. There are two specific purposes to the study: 1. whether the different x-ray and MRI techniques will give the same or different information about the knee joint and 2. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- X-ray; magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Feb 2009
- 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female, 40 years and older, community sample
Who may be able to join
- Female
- 40 years and older
- Subjects who are willing and able to comply with x-ray and MRI procedures
- Evidence of a personally signed and dated consent document
- Additional inclusion for normal controls:
- Infrequent knee pain, aching, or stiffness during the past year or infrequent use of medication for treatment of knee pain during the past year
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- No evidence of OA on either knee (i.e. K-L grade = 0 diagnosed by knee radiography)
- Additional inclusion for OA patients:
- Pain, aching, or stiffness on most days of a month during the past year; or use of medication for treatment of knee pain on most days of a month during the past year
- Kellgren-Lawrence Grade 2 or 3 of the study knee obtained on a Standard knee radiograph (with either the same or less severe OA, or no OA in the contralateral knee)
Who cannot join
- Subject is unable to undergo MRI because of contraindication
- Women at risk of pregnancy
- Weight greater than 250 lbs
- History of surgery in the study knee
- History of other diseases involving the study knee joint including inflammatory joint diseases, crystalline disease, and infection of the study knee
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California - San Francisco
San Francisco, California, 94107
About this study
Official title: Weight-Bearing MRI for Analysis of Knee OA
The purpose of the study is to use different x-ray and magnetic resonance (MR) imaging techniques to take pictures of the knee. There are two specific purposes to the study:
- whether the different x-ray and MRI techniques will give the same or different information about the knee joint and
- which part of the knee joint will show the biggest change using the different x-ray and MRI techniques. The study is not designed to test a hypothesis.
- Conditions
- Osteoarthritis
- Being tested
- X-ray; magnetic resonance imaging
- Keywords
- Knee Osteoarthritis, magnetic resonance imaging, x rays
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-ray; magnetic resonance imagingRadiation
Knee x-rays: acquired in both a standard or weight-bearing position and in non-weight-bearing position to measure joint space width and look at signs of osteoarthritis.
3 Tesla MRI: magnetic resonance imaging of the study knee during weight-bearing conditions and traditional non-loaded condition all acquired with the same sequences.
| Study group | Role | What they receive |
|---|---|---|
| Normal Subjects | Female subjects scoring Kellgren \& Lawrence grade 0. Receives: Radiation: X-ray; magnetic resonance imaging | |
| OA Subjects | Female subjects with Kellgren \& Lawrence score of 2 or 3. Receives: Radiation: X-ray; magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols.
Measured: at time of scan
Secondary outcomes (1)
Determine if additional information gained from weight-bearing images can explain the difference in joint space width (JSW) between weight-bearing x-ray and traditional non-weight bearing MRI.
Measured: at time of scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2009
- Study completionFeb 2009
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.
- More trials run by University of California, San FranciscoThe 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Sharmila Majumdar, PhD, Principal investigator, University of California, San FranciscoThomas Link, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665548
- Sponsor's protocol ID
- Pfizer West
- Status last verified
- Mar 2008
- First submitted
- 22 Apr 2008
- Last updated
- 17 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight-Bearing MRI for Analysis of Knee OA
- ClinicalTrials.gov ID
- NCT00665548
- Acronym / sponsor ID
- Pfizer West
- Conditions
- Osteoarthritis
- Keywords
- Knee Osteoarthritis, magnetic resonance imaging, x rays
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 Apr 2008 (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 use different x-ray and magnetic resonance (MR) imaging techniques to take pictures of the knee. There are two specific purposes to the study:
- whether the different x-ray and MRI techniques will give the same or different information about the knee joint and
- which part of the knee joint will show the biggest change using the different x-ray and MRI techniques. The study is not designed to test a hypothesis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Subjects | – | Radiation: X-ray; magnetic resonance imagingFemale subjects scoring Kellgren \& Lawrence grade 0. |
| OA Subjects | – | Radiation: X-ray; magnetic resonance imagingFemale subjects with Kellgren \& Lawrence score of 2 or 3. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Female, 40 years and older, community sample
Key inclusion criteria (10 listed)
- Female
- 40 years and older
- Subjects who are willing and able to comply with x-ray and MRI procedures
- Evidence of a personally signed and dated consent document
- Infrequent knee pain, aching, or stiffness during the past year or infrequent use of medication for treatment of knee pain during the past year
Key exclusion criteria (5 listed)
- Subject is unable to undergo MRI because of contraindication
- Women at risk of pregnancy
- Weight greater than 250 lbs
- History of surgery in the study knee
- History of other diseases involving the study knee joint including inflammatory joint diseases, crystalline disease, and infection of the study knee
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 |
|---|---|---|
| X-ray; magnetic resonance imagingKnee x-rays: acquired in both a standard or weight-bearing position and in non-weight-bearing position to measure joint space width and look at signs of osteoarthritis. 3 Tesla MRI: magnetic resonance imaging of the study knee during weight-bearing conditions and traditional non-loaded condition all acquired with the same sequences. | Radiation | Normal Subjects, OA Subjects |
Primary outcome
Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols.
Time frame: at time of scan
1 secondary outcome
Determine if additional information gained from weight-bearing images can explain the difference in joint space width (JSW) between weight-bearing x-ray and traditional non-weight bearing MRI.
Time frame: at time of scan
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 17 Apr 2009.
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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.
Sharmila Majumdar, PhD principal investigator
University of California, San Francisco
Thomas Link, MD principal investigator
University of California, San Francisco
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, run by University of California, San Francisco at 1 site in United States.
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 10 inclusion and 5 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 17 Apr 2009. 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 United States. 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?
Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols. (time frame: at time of scan). 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 17 Apr 2009.