Skip to main content
OpenTrials
Completed

NCT Number: NCT00504114

MR Imaging of Knee Osteoarthritis and Acute Knee Injuries

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco; MR Surbeck Laboratory of Advanced Imaging

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

ACL Reconstruction Surgery

Procedure

Cartilage Resurfacing Surgery

Procedure

Total Knee Replacement

Procedure

Primary outcomes

  1. Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes

    Time frame: Baseline, 1 year, 2 year, 3 year

Secondary outcomes

  1. Evaluate T1rho relaxation methods and its' relation to cartilage loss

    Time frame: Baseline, 1 year, 2 year, 3 year

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Jul 19, 2007
Registry last updated
Dec 12, 2013

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.

Published trials that share one or more normalized conditions with this study.