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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Euflexxa | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Euflexxa | Drug | Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection | 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To Quantify Cartilage Matrix Changes Using MR T1p ad T2 Mapping at 3T MRI | 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaojuan Li, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF - China Basin Imaging Center | San Francisco | California | 94107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Subjects treated with Euflexxa |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Magnetic Resonance Imaging (MRI) | Device | 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). |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Subjects treated with Euflexxa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | To Identify Imaging Markers for Characterizing the Biochemical Profiles in Synovial Fluid and Cartilage in Knee OA After HA Injection | 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. | The PI left institution and all efforts to locate outcome measure data have been exhausted and therefore cannot be reported. | Posted | 3 months |
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| Secondary | To Quantify Synovial Fluid Biochemical Changes Using High Field HRMAS NMR Spectroscopy | The PI left institution and all efforts to locate outcome measure data have been exhausted and therefore cannot be reported. | Posted | 3 months |
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| ||||||||||||||||||||
| Other Pre-specified | To Quantify Cartilage Matrix Changes Using MR T1p ad T2 Mapping at 3T MRI | The PI left institution and all efforts to locate outcome measure data have been exhausted and therefore cannot be reported. | Posted | 3 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Subjects treated with Euflexxa | 0 | 12 | 0 | 12 | 1 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Xiaojuan Li, PhD | University of California, San Francisco | 415-353-4909 | Xiaojuan.li@ucsf.edu |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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