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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00665548
First received: April 22, 2008
Last updated: April 16, 2009
Last verified: March 2008
History of Changes
  Purpose

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.

Condition Intervention
Osteoarthritis
 Radiation: X-ray; magnetic resonance imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Weight-Bearing MRI for Analysis of Knee OA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols. [ Time Frame: at time of scan ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: at time of scan ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: March 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Normal Subjects
Female subjects scoring Kellgren & Lawrence grade 0.
 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.
OA Subjects
Female subjects with Kellgren & Lawrence score of 2 or 3.
 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Female, 40 years and older, community sample

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00665548

Locations
United States, California
University of California - San Francisco
San Francisco, California, United States, 94107
Sponsors and Collaborators
University of California, San Francisco
Pfizer
Investigators
Principal Investigator: Sharmila Majumdar, PhD University of California, San Francisco
Principal Investigator: Thomas Link, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Sharmila Majumdar, PhD, UCalifroniaSF
ClinicalTrials.gov Identifier: NCT00665548     History of Changes
Other Study ID Numbers: Pfizer West
Study First Received: April 22, 2008
Last Updated: April 16, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Knee Osteoarthritis
magnetic resonance imaging
x rays

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013