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A study using characteristics on ultrasound to predict response to intraarticular steroid injections in patients with knee osteoarthritis. The hypothesis is that patients with inflammation on ultrasound will have a better response to corticosteroid injections compared to patients without inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid Injection | Active Comparator | 40 mg of intraarticular triamcinolone acetonide |
|
| Placebo Injection | Placebo Comparator | Intraarticular injection of 0.9% saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triamcinolone acetonide | Drug | single intraarticular injection of 40 mg of triamcinolone acetonide |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale | WOMAC pain subscale range 0-20 (0=best, 20=worst) | baseline to 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in WOMAC Pain Subscale | WOMAC pain subscale range 0-20 (0=best, 20=worst) | baseline to 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Kalunian, MD | University of California, San Diego | Principal Investigator |
| Anna Quan, MD | San Diego VA Hospital | Study Chair |
| Michal Kalli Hose, MD | San Diego VA Hospital | Study Director |
| Jeannie Chao, MD | University of California, San Diego | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego Medical Center | La Jolla | California | 92093 | United States | ||
| San Diego VA Hospital |
Patients taking oral corticosteroids, who had a primary inflammatory connective tissue disease, or who received IA corticosteroids in the affected knee within three months of study entry were excluded from the study.
Patients were recruited in rheumatology clinics at UCSD and the VA musculoskeletal clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Corticosteroid Injection | 40 mg of intraarticular triamcinolone acetonide |
| FG001 | Placebo | Intraarticular injection of 0.9% saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Corticosteroid Injection | 40 mg of intraarticular triamcinolone acetonide |
| BG001 | Placebo | Intraarticular injection of 0.9% saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Western Ontario and McMasters Universities Arthritis Index (WOMAC) Pain Subscale | WOMAC pain subscale range 0-20 (0=best, 20=worst) | This population was defined as patients who completed the 4 week follow up assessment as per protocol. | Posted | Mean | Standard Deviation | units on a scale | baseline to 4 weeks |
|
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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 | Corticosteroid Injection | 40 mg of intraarticular triamcinolone acetonide |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeannie Chao | UCSD | 858-657-7040 | j5chao@ucsd.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| saline | Drug | Single intraarticular injection of 1 ml of 0.9% saline |
|
| La Jolla |
| California |
| 92161 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Other Pre-specified | Change in WOMAC Pain Subscale | WOMAC pain subscale range 0-20 (0=best, 20=worst) | These patients were categorized as inflammatory or noninflammatory based on the baseline ultrasound characteristics. All patients were in the treatment group. | Posted | Mean | Standard Deviation | units on a scale | baseline to 12 weeks |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo | Intraarticular injection of 0.9% saline | 0 | 39 | 0 | 39 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |