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OpenTrials
Completed

NCT Number: NCT00665548

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

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.

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of California - San Francisco

San Francisco, California, 94107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

X-ray; magnetic resonance imaging

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.

Primary outcomes

  1. Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols.

    Time frame: at time of scan

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Pfizer

Registry information

Official study title

Weight-Bearing MRI for Analysis of Knee OA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 24, 2008
Registry last updated
Apr 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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