Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA)
NCT00665548
ABOUT THIS STUDY
FOR MORE INFORMATION
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Adult Trials: 18+ Years
- 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
- 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)
- 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
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA) | ||||||
| Official Title | Weight-Bearing MRI for Analysis of Knee OA | ||||||
| Brief 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:
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| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Female, 40 years and older, community sample | ||||||
| Condition | Osteoarthritis | ||||||
| Intervention | Radiation: X-ray; magnetic resonance imaging
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 Groups/Cohorts |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Estimated Enrollment | 33 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Actual Study Completion Date | February 2009 | ||||||
| Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion Criteria:
Additional inclusion for normal controls:
Additional inclusion for OA patients:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 40 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | Yes | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT00665548 | ||||||
| Other Study ID Numbers | Pfizer West | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement | Not Provided | ||||||
| Responsible Party | Sharmila Majumdar, PhD, UCalifroniaSF | ||||||
| Study Sponsor | University of California, San Francisco | ||||||
| Collaborators | Pfizer | ||||||
| Investigators |
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| PRS Account | University of California, San Francisco | ||||||
| Verification Date | March 2008 | ||||||