Clinical trial NCT00665548: Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA)
Official title: Weight-Bearing MRI for Analysis of Knee OA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Keywords: Knee Osteoarthritis
magnetic resonance imaging
x rays
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-04-24
Enrollment: 33
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female, 40 years and older, community sample

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:

1. whether the different x-ray and MRI techniques will give the same or different information about the knee joint and
2. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols.
timeFrame: at time of scan
Secondary outcomes:
measure: 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.
timeFrame: at time of scan
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sharmila Majumdar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Thomas Link, MD
role: PRINCIPAL_INVESTIGATOR
References: