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| ID | Type | Description | Link |
|---|---|---|---|
| 101584 | |||
| Grant# K23AR050607-01 |
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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to find out if hyaluronan, an injectable medication for knee arthritis, also works for arthritis at the base of the thumb. This study will also evaluate how good ultrasound is at visualizing medication in the thumb joint. We are no longer recruiting for this part of the open label trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilot Study of Hylan G-F 20 | Experimental | 32 Subjects have received Synvisc Injections and followed for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synvisc (hylan G-F20) | Device | 32 subjects in the pilot study have received 3 1ml injections of Synvisc intraarticular over the course of 3 weeks and then followed for 6 months post injection |
| Measure | Description | Time Frame |
|---|---|---|
| The Disabilities of the Arm, Shoulder and Hand Outcome Measure | The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded. | 26 weeks (6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale for Pain | The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded. | 26 weeks (6 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Mandl, MD MPH | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19601706 | Derived | Mandl LA, Hotchkiss RN, Adler RS, Lyman S, Daluiski A, Wolfe SW, Katz JN. Injectable hyaluronan for the treatment of carpometacarpal osteoarthritis: open label pilot trial. Curr Med Res Opin. 2009 Sep;25(9):2103-8. doi: 10.1185/03007990903084016. |
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Exclusion criteria included: age < 45, systemic rheumatic disease, self-reported comorbid hand conditions, history of gout or pseudogout, bleeding diatheses, previous surgery to the involved thumb, and no evidence of CMC joint space narrowing. Patients must have failed some form of conservative therapy, such as NSAIDS, acetaminophen or splinting.
Patients with painful CMC OA and radiographic changes of Kellgren and Lawrence (K+L) Grade 2-4 were recruited from rheumatology and hand surgery practices at the Hospital for Special Surgery from 2004-2005
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| ID | Title | Description |
|---|---|---|
| FG000 | Synvisc Group | Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The average baseline VAS for pain was 62(range 38-100), and DASH was 29.7 (range 1- 68). 53% had ≥ 1 previous corticosteroid injection. All patients had moderate or severe radiographic OA of the CMC joint: 59% were K+L Grade 4, 25% Grade 3, and 16% Grade 2. No patients had clinical evidence of carpal tunnel syndrome or DeQuervain's tenosynovitis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label Group | Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | The Disabilities of the Arm, Shoulder and Hand Outcome Measure | The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. Scores are transformed to a 0-100 scale, with a higher value indicating greater disability. The change in DASH (delta) over those 6 months was recorded. | Posted | Mean | Standard Deviation | units on a scale | 26 weeks (6 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 | Open Label Group | Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unlikely Related Pseudogout | Musculoskeletal and connective tissue disorders | One patient had an acute attack of crystal proven pseudogout in the ipsilateral wrist 33 days after the last CMC hyaluronic acid injection. The patient had no previous history of inflammatory arthritis and had been well in the interim. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at Injection Site | Musculoskeletal and connective tissue disorders | Out of the 96 total injections, 3 resulted in post-injection pain and swelling requiring treatment. Two were after the second injection, and one was after the third injection. All symptoms rapidly resolved with ice, NSAIDS or COX-2 inhibitor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Mandl | Hospital for Special Surgery | 212-774-2555 | MandlL@hss.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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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Visual Analog Scale for Pain | The visual analog scale for pain (VAS) is a test requiring a patient to indicate along a line how much pain they are experiencing between 0-100. A score of 100 indicates the maximum possible pain level and a score of 0 indicates no pain. Scores are recorded as whole number integers. The change in VAS (delta) over those 6 months was recorded. | Posted | Mean | Standard Deviation | mm | 26 weeks (6 months) |
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| 3 |
| 32 |
| 3 |
| 32 |
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| Unlikely Related GI Bleed | Gastrointestinal disorders | A 74 year old patient withdrew after a gastrointestinal bleed that occurred 69 days after the last HA injection. |
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| Possibly but Unlikely Related Fall | Musculoskeletal and connective tissue disorders | One patient slipped on the way to the hospital for the third HA injection and suffered a broken scapula; this patient completed the study. |
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