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CompletedNCT00504114Updated Dec 12, 2013

MR Imaging of Knee Osteoarthritis and Acute Knee Injuries

An observational study in Osteoarthritis, Knee, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-12.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
139
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • Osteoarthritis, knee
  • anterior cruciate ligament
  • Magnetic Resonance Imaging
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 139 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
139 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

Interventions

  • ProcedureACL Reconstruction Surgery
  • ProcedureCartilage Resurfacing Surgery
  • ProcedureTotal Knee Replacement
06

What researchers measure

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

07

Study locations

1 site
  • University of California, San Francisco; MR Surbeck Laboratory of Advanced Imaging
    San Francisco, California 94158, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00504114
Lead sponsor
University of California, San Francisco
Collaborators
National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Jul 19, 2007
Start date
Aug 2006
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Dec 12, 2013

Study contacts

Sharmila Majumdar, Ph.D.
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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