MR Imaging of Knee Osteoarthritis and Acute Knee Injuries
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00504114|
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : December 12, 2013
|Condition or disease||Intervention/treatment|
|Osteoarthritis, Knee||Procedure: ACL Reconstruction Surgery Procedure: Cartilage Resurfacing Surgery Procedure: Total Knee Replacement|
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|
|Actual Enrollment :||139 participants|
|Observational Model:||Case Control|
|Official Title:||MR Imaging of Knee Osteoarthritis and Acute Knee Injuries|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Healthy volunteers without knee pain.
Patients with mild arthritic symptoms and radiographic changes (Kellgren Lawrence score of 1, 2)
Patients with severe pain and functional limitations associated with knee arthritis (Kellgren Lawrence score of 3, 4).
Procedure: Total Knee Replacement
Patients with acute anterior cruciate ligament (ACL) injuries with associated osseous contusion.
Procedure: ACL Reconstruction Surgery
Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures.
Procedure: Cartilage Resurfacing Surgery
- Pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
- Evaluate T1rho relaxation methods and its' relation to cartilage loss [ Time Frame: Baseline, 1 year, 2 year, 3 year ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504114
|United States, California|
|University of California, San Francisco; MR Surbeck Laboratory of Advanced Imaging|
|San Francisco, California, United States, 94158|
|Principal Investigator:||Sharmila Majumdar, Ph.D.||University of California, San Francisco|