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

NCT00665548 | Completed

• 1 other identifier: Pfizer West
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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. 1.whether the different x-ray and MRI techniques will give the same or different information about the knee joint and
2. 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.

Conditions

Osteoarthritis

Keywords

Knee Osteoarthritis; magnetic resonance imaging; x rays

Outcome Measures

Primary Outcomes (1)

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

  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.

  at time of scan

Study Arms (2)

Normal Subjects

Female subjects scoring Kellgren \& Lawrence grade 0.

Radiation: X-ray; magnetic resonance imaging

OA Subjects

Female subjects with Kellgren \& Lawrence score of 2 or 3.

Radiation: X-ray; magnetic resonance imaging

Interventions

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.

Normal Subjects; OA Subjects

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female, 40 years and older, community sample

You may qualify if:

• Female
• 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
• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Pfizer: collaborator

Study Sites (1)

University of California - San Francisco

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee

Interventions

X-Rays; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Sharmila Majumdar, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Thomas Link, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 22, 2008
• First Posted: April 24, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 17, 2009

Record last verified: 2008-03

Locations

US (1)