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MR Imaging of Knee Osteoarthritis and Acute Knee Injuries

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ClinicalTrials.gov Identifier: NCT00504114
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : December 12, 2013
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, San Francisco

July 17, 2007
July 19, 2007
December 12, 2013
August 2006
July 2013   (Final data collection date for primary outcome measure)
Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
Not Provided
Complete list of historical versions of study NCT00504114 on ClinicalTrials.gov Archive Site
Evaluate T1rho relaxation methods and its' relation to cartilage loss [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
Not Provided
Not Provided
Not Provided
 
MR Imaging of Knee Osteoarthritis and Acute Knee Injuries
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Bone/cartilage tissue will be collected after the total knee replacement surgery. The tissue will further studied using advanced MR imaging techniques.
Non-Probability Sample
Recruitment flyers are posted at different UCSF campuses and those staff and students. Patient eligibility will determined initially bye the referring orthopedist.
Osteoarthritis, Knee
  • Procedure: ACL Reconstruction Surgery
  • Procedure: Cartilage Resurfacing Surgery
  • Procedure: Total Knee Replacement
  • 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).
    Intervention: Procedure: Total Knee Replacement
  • 4
    Patients with acute anterior cruciate ligament (ACL) injuries with associated osseous contusion.
    Intervention: Procedure: ACL Reconstruction Surgery
  • 5
    Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures.
    Intervention: Procedure: Cartilage Resurfacing Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
145
July 2013
July 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00504114
2R01AR046905( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
University of California, San Francisco
University of California, San Francisco
National Institutes of Health (NIH)
Principal Investigator: Sharmila Majumdar, Ph.D. University of California, San Francisco
University of California, San Francisco
December 2013