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Sponsors and Collaborators: |
University of California, San Francisco National Institutes of Health (NIH) |
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Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00504114 |
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.
Condition | Intervention |
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Osteoarthritis, Knee Anterior Cruciate Ligament Magnetic Resonance Imaging |
Procedure: ACL Reconstruction Surgery Procedure: Cartilage Resurfacing Surgery Procedure: Total Knee Replacement |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | MR Imaging of Knee Osteoarthritis and Acute Knee Injuries |
Bone/cartilage tissue will be collected after the total knee replacement surgery. The tissue will further studied using advanced MR imaging techniques.
Estimated Enrollment: | 145 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | December 2012 |
Groups/Cohorts | Assigned Interventions |
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Healthy volunteers without knee pain.
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Patients with mild arthritic symptoms and radiographic changes (Kellgren Lawrence score of 1, 2)
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3
Patients with severe pain and functional limitations associated with knee arthritis (Kellgren Lawrence score of 3, 4).
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Procedure: Total Knee Replacement |
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Patients with acute anterior cruciate ligament (ACL) injuries with associated osseous contusion.
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Procedure: ACL Reconstruction Surgery |
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Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures.
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Procedure: Cartilage Resurfacing Surgery |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | 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.
Inclusion Criteria:
Exclusion Criteria:
Contact: Thelma Munoz, M.D. | 415-353-9446 | thelma.munoz@radiology.ucsf.edu |
Contact: Melissa Guan | 415-353-4216 | melissa.guan@radiology.ucsf.edu |
United States, California | |
University of California, San Francisco; MR Surbeck Laboratory of Advanced Imaging | Recruiting |
San Francisco, California, United States, 94158 | |
Principal Investigator: Sharmila Majumdar, Ph.D. |
Principal Investigator: | Sharmila Majumdar, Ph.D. | University of California, San Francisco |
Responsible Party: | University of California, San Francisco ( Sharmila Majumdar, Ph.D. ) |
Study ID Numbers: | 2R01AR046905 |
Study First Received: | July 17, 2007 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00504114 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Osteoarthritis, knee anterior cruciate ligament Magnetic Resonance Imaging |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis |
Wounds and Injuries Disorders of Environmental Origin Knee Injuries Leg Injuries Rheumatic Diseases |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis |
Wounds and Injuries Disorders of Environmental Origin Knee Injuries Leg Injuries Rheumatic Diseases |