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- Klinische proef NCT00665548
Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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California
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San Francisco, California, Verenigde Staten, 94107
- University of California - San Francisco
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
Normal Subjects
Female subjects scoring Kellgren & Lawrence grade 0.
|
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. |
OA Subjects
Female subjects with Kellgren & Lawrence score of 2 or 3.
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols.
Tijdsspanne: at time of scan
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at time of scan
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
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.
Tijdsspanne: at time of scan
|
at time of scan
|
Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Sharmila Majumdar, PhD, University of California, San Francisco
- Hoofdonderzoeker: Thomas Link, MD, University of California, San Francisco
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Pfizer West
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