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

Osteoarthritis Clinical Trial

Official title:

Weight-Bearing MRI for Analysis of Knee OA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665548
• Other study ID #: Pfizer West
• Status: Completed
• Phase: N/A
• First received: April 22, 2008
• Last updated: April 16, 2009
• Start date: March 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2008
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

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.

Locations

Country	Name	City	State
United States	University of California - San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine which joint components demonstrate the greatest changes between weight-bearing and non weight-bearing protocols.		at time of scan	No
Secondary	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.		at time of scan	No