To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection
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|ClinicalTrials.gov Identifier: NCT01895959|
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : May 16, 2017
The purpose of this study is to identify novel imaging markers for characterizing the biochemical profiles in synovial fluid and cartilage matrix in OA knee joints after intra-articular HA (Euflexxa) injection using high field NMR and MRI techniques.
We hypothesize that:
- High-field HRMAS NMR spectroscopy will provide sensitive measures for biochemical changes within knee synovial fluid after HA injection;
- Baseline HRMAS spectroscopy, in particular N-acetyl peaks, as well as early changes of glutamate will predict patient response of pain relief after HA injection;
- MR cartilage T1p and T2 quantifications will provide sensitive measures for biochemical changes within knee cartilage matrix after HA injection. Specifically cartilage T1p and T2 will decrease in patients who respond to the treatment, indicating potential beneficial effects of HA injection to cartilage preservation.
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Drug: Euflexxa Device: Magnetic Resonance Imaging (MRI)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Quantifications of Biochemical Changes of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection Using Novel MRI (Magnetic Resonance Imaging) and NMR (Nuclear Magnetic Resonance) Techniques|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||January 2017|
EUFLEXXA® is a hyaluronate hydrogel produced from bacteria, in a phosphate-buffered saline solution. It is given as a three week treatment regimen. It involves injecting of 2cc or 20mg intra-articularly once per week.
Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.
Other Name: hyaluronic acid injectionDevice: Magnetic Resonance Imaging (MRI)
MRI of the knee will be acquired during baseline (a week prior to the treatment), follow up visit 1 (1 week after treatment) and follow up visit 2 (3 months after treatment).
- To identify imaging markers for characterizing the biochemical profiles in synovial fluid and cartilage in knee OA after HA injection [ Time Frame: 3 months ]The study will demonstrate the feasibility of using MRI and NMR techniques to quantify biochemical changes in synovial fluid and cartilage matrix in OA knees after HA injection.
- To quantify synovial fluid biochemical changes using high field HRMAS NMR spectroscopy [ Time Frame: 3 months ]
- To quantify cartilage matrix changes using MR T1p ad T2 mapping at 3T MRI [ Time Frame: 3 months ]
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): NCT01895959
|United States, California|
|UCSF - China Basin Imaging Center|
|San Francisco, California, United States, 94107|
|Principal Investigator:||Xiaojuan Li, PhD||University of California, San Francisco|