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Trial record 1 of 1 for:    NCT00665548
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Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA)

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ClinicalTrials.gov Identifier: NCT00665548
Recruitment Status : Completed
First Posted : April 24, 2008
Last Update Posted : April 17, 2009
Sponsor:
Collaborator:
Pfizer
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date April 22, 2008
First Posted Date April 24, 2008
Last Update Posted Date April 17, 2009
Study Start Date March 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 23, 2008)
Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols. [ Time Frame: at time of scan ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 23, 2008)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Weight-Bearing Magnetic Resonance Imaging (MRI) for Analysis of Knee Osteoarthritis (OA)
Official Title Weight-Bearing MRI for Analysis of Knee OA
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Female, 40 years and older, community sample
Condition Osteoarthritis
Intervention 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.

Study Groups/Cohorts
  • Normal Subjects
    Female subjects scoring Kellgren & Lawrence grade 0.
    Intervention: Radiation: X-ray; magnetic resonance imaging
  • OA Subjects
    Female subjects with Kellgren & Lawrence score of 2 or 3.
    Intervention: Radiation: X-ray; magnetic resonance imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: April 23, 2008)
33
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00665548
Other Study ID Numbers Pfizer West
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sharmila Majumdar, PhD, UCalifroniaSF
Study Sponsor University of California, San Francisco
Collaborators Pfizer
Investigators
Principal Investigator: Sharmila Majumdar, PhD University of California, San Francisco
Principal Investigator: Thomas Link, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date March 2008