- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
-
California
-
San Francisco, California, Forenede Stater, 94107
- University of California - San Francisco
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols.
Tidsramme: at time of scan
|
at time of scan
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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.
Tidsramme: at time of scan
|
at time of scan
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sharmila Majumdar, PhD, University of California, San Francisco
- Ledende efterforsker: Thomas Link, MD, University of California, San Francisco
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pfizer West
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