MR Imaging of Knee Osteoarthritis and Acute Knee Injuries

December 11, 2013 updated by: University of California, San Francisco
The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to examine the knee and the bony and soft tissue changes so as to better predict the progression of osteoarthritis and acute knee injuries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will examine the pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes; and evaluate T1p relaxation methods and its' relating to cartilage loss. The protocol is geared towards sequences utilizing 3 Tesla magnetic resonance imaging (MRI) that will enable the measures of cartilage volume and T2. Measures cartilage volume and T2 are more established MR methods for studying osteoarthritis (OA).

All OA and Anterior cruciate ligament (ACL) subjects will undergo MR imaging of the knee joint at 3 Tesla at baseline,, and three annual follow up time points. Regions of interest will include the total tibial and femoral cartilage, and sub-division such as the medial and lateral compartments of the tibial and femoral cartilage to account for localized disease activity and progression.

Bone marrow edema size, MR spectroscopy based marrow fat/water content, and trabecular bone microarchitecture underlying the edema will be measured in the OA and ACL groups to determine whether there is any distinction between these measures in OA and in traumatic ACL injury, cross-sectionally and longitudinally, and their relation to cartilage loss and OA progression.

Study Type

Observational

Enrollment (Actual)

139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco; MR Surbeck Laboratory of Advanced Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Recruitment flyers are posted at different UCSF campuses and those staff and students. Patient eligibility will determined initially bye the referring orthopedist.

Description

Inclusion Criteria:

  • Healthy volunteers will have had no previous knee symptoms or surgery
  • Patients with mild arthritic symptoms and Kellgren Lawrence score of 2
  • Patients with severe arthritic symptoms and Kellgren Lawrence score of 3, or 4
  • Patients with acute ACL injury with associated bone contusion and bone edema
  • Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures
  • Patient is willing to participate in the proposed study as evidenced by providing written informed consent.

Exclusion Criteria:

  • Current use of an investigational drug
  • Conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy or a stroke.)
  • Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Healthy volunteers without knee pain.
2
Patients with mild arthritic symptoms and radiographic changes (Kellgren Lawrence score of 1, 2)
3
Patients with severe pain and functional limitations associated with knee arthritis (Kellgren Lawrence score of 3, 4).
Procedure: Total Knee Replacement
4
Patients with acute anterior cruciate ligament (ACL) injuries with associated osseous contusion.
Procedure: ACL Reconstruction Surgery
5
Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures.
Procedure: Cartilage Resurfacing Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes
Time Frame: Baseline, 1 year, 2 year, 3 year
Baseline, 1 year, 2 year, 3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate T1rho relaxation methods and its' relation to cartilage loss
Time Frame: Baseline, 1 year, 2 year, 3 year
Baseline, 1 year, 2 year, 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Sharmila Majumdar, Ph.D., University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 17, 2007

First Submitted That Met QC Criteria

July 17, 2007

First Posted (Estimate)

July 19, 2007

Study Record Updates

Last Update Posted (Estimate)

December 12, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R01AR046905 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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