Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA)

NCT ID: NCT00665548

Last Updated: 2009-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Normal Subjects

Female subjects scoring Kellgren \& Lawrence grade 0.

X-ray; magnetic resonance imaging

Intervention Type RADIATION

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.

X-ray; magnetic resonance imaging

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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UCalifroniaSF

Principal Investigators

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Sharmila Majumdar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Thomas Link, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California - San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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Pfizer West

Identifier Type: -

Identifier Source: org_study_id

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